<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02968979</url>
  </required_header>
  <id_info>
    <org_study_id>CPF-ANA-001</org_study_id>
    <nct_id>NCT02968979</nct_id>
  </id_info>
  <brief_title>Non-interventional Study to Assess the Frequency of Cachexia in Patients With Non-small Cell Lung Cancer.</brief_title>
  <acronym>CacheMire</acronym>
  <official_title>Cross-sectional, Multicentric, Non-interventional Study to Assess the Frequency and the Management of Cachexia and Associated Symptoms in Patients With Non-small Cell Lung Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chugai Pharma France</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>French College of General Hospital Pneumologists (CPHG)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>French-Speaking Association of Supportive Care in Cancer (AFSOS)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ITEC Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chugai Pharma France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the frequency of cachexia and the management of&#xD;
      cachexia and associated symptoms in a patient population with non-small cell lung cancer&#xD;
      (NSCLC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a cross-sectional, non-interventional, European (France and Belgium), multicentric&#xD;
      prevalence study, conducted on a representative population of 500 patients with NSCLC, to&#xD;
      assess the frequency and the management of cachexia and associated symptoms.&#xD;
&#xD;
      The study will be conducted in accordance with the professional code of ethics and the good&#xD;
      epidemiological practices guidelines developed by the ADELF (the Association of&#xD;
      French-Speaking Epidemiologists) and in accordance with the STROBE recommendations for the&#xD;
      drafting of reports and publications related to the study.&#xD;
&#xD;
      The information will be collected during a single visit to the oncologist/lung specialist as&#xD;
      part of the usual patient management of his/her lung cancer. The physician will explain the&#xD;
      purpose of the study to the patient with an information form specific to the study and will&#xD;
      inform him/her of the option to refuse or withdraw from participation. The patient&#xD;
      information form in France or a specific consent form in Belgium will be signed by the&#xD;
      patient and a copy will be given to him/her (the original will be kept by the physician).&#xD;
&#xD;
      This study does not require any additional specific data. Data will come from the medical&#xD;
      file and from the routine disease management. Furthermore, the following self-completion&#xD;
      questionnaires will be proposed to patients: Visual analogue scale for dietary intake&#xD;
      (dietary intake VAS), assessment of the concerns associated with the anorexia/cachexia&#xD;
      (Anorexia-Cachexia module of the Functional Assessment of Anorexia/Cachexia Therapy [FAACT]&#xD;
      questionnaire), quality of life (EORTC QLQ-C30), and assessment of physical activity (IPAQ,&#xD;
      International Physical Activity Questionnaire). Abdominal CT-scan, if available, will be&#xD;
      collected for assessment of skeletal muscle mass index at L3.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2016</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of Cachexia According to Modified Fearon Criteria</measure>
    <time_frame>Day1</time_frame>
    <description>Percentage of NSCLC patients with a cachexia according to Fearon criteria modified for the stages of pre-cachexia and refractory cachexia in order to classify all the featured cases without ambiguity.&#xD;
A patient was considered to have cachexia if he/she had:&#xD;
Weight loss &gt;5% in the last 6 months prior to inclusion or&#xD;
BMI &lt;20 kg/m² and weight loss between 2 and 5% in the 6 months prior to inclusion or&#xD;
Weight loss &gt;2% and sarcopenia (as evaluated by the muscle mass index at L3) if available. If data were not available regarding possible sarcopenia, the presence of cachexia was assigned based on the 2 above conditions.&#xD;
In the 3 cases defined above, patient should not have entered the refractory cachexia stage, which was defined as: ECOG performance score of 3 or 4 and a low survival expectancy as defined by Martin et al. (J Clin Oncol 2015) (BMI &lt;20 kg/m² and weight loss ≥ 6%) or (20 ≤ BMI ≤ 21.9 kg/m² and weight loss ≥ 11%) or (22 kg/m² ≤ BMI and weight loss ≥ 15%).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of the Different Stages of Cachexia in the General NSCLC Population</measure>
    <time_frame>Day 1</time_frame>
    <description>Percentage of the different stages of cachexia at inclusion.&#xD;
The different stages of cachexia used the following classification:&#xD;
No Cachexia: 1) no weight loss (WL&lt;2%) or 2) weight gain AND no anorexia AND no sarcopenia&#xD;
The pre-cachexia stage : 1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss &lt; 2% AND sarcopenia&#xD;
Cachexia: 1) Weight loss &gt; 5% OR 2) weight loss between 2 and 5% AND BMI &lt; 20 kg/m² OR 3) weight loss &gt; 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage&#xD;
Refractory cachexia: ECOG 3 or 4 AND low survival expectancy [BMI &lt; 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Stage Associated With NSCLC.</measure>
    <time_frame>Day 1</time_frame>
    <description>Percentage of the different stages of cachexia at inclusion according to the NSCLC stage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Histology Associated With NSCLC.</measure>
    <time_frame>Day 1</time_frame>
    <description>Percentage of the different stages of cachexia according to the NSCLC histology</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Sarcopenia in the General NSCLC Patients With Cachexia</measure>
    <time_frame>Day 1</time_frame>
    <description>Percentage of patients with sarcopenia in the general NSCLC patients with cachexia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Sarcopenia With no Clinical Significant Weight Loss in the General NSCLC Patients With Pre-cachexia</measure>
    <time_frame>Day 1</time_frame>
    <description>Percentage of patient with sarcopenia and no clinical significant weight loss (sarcopenia and WL&lt; 2%) in the general NSCLC patients with pre-cachexia:</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC.</measure>
    <time_frame>Day 1</time_frame>
    <description>Percentage of the different stages of cachexia according to the molecular abnormalities associated with NSCLC:&#xD;
EGRF, ALK, ROS1, BRAF or HER2&#xD;
K-RAS&#xD;
No mutation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of the Different Stages of Cachexia According to the Number of Treatments Received.</measure>
    <time_frame>Day 1</time_frame>
    <description>NSCLC patients. 84 patients with missing data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of the Different Stages of Cachexia According to the Types of Treatments Received.</measure>
    <time_frame>Day 1</time_frame>
    <description>Stage of cachexia at inclusion according to the type of treatments received (surgery, radiotherapy, chemotherapy, targeted therapies).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Nutritional State</measure>
    <time_frame>Day 1</time_frame>
    <description>• Nutritional state according to the different stages of cachexia The variables used will be: serum albumin levels, serum pre-albumin levels, BMI and weight.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Blood Glucose</measure>
    <time_frame>Day 1</time_frame>
    <description>Blood glucose abnormalities according to the different stages of cachexia at inclusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - Dietary Intake Visual Analog Scale</measure>
    <time_frame>Day 1</time_frame>
    <description>Dietary Intake Visual Analog Scale (Dietary intake VAS): The question &quot;Could you indicate the amount you currently eat, placing a vertical mark on the line between &quot;nothing at all&quot; and &quot;as usual&quot;? &quot;. Depending on the location of the patient mark on the scale, a score of between 0 (&quot;nothing at all&quot;) and 10 (&quot;as usual&quot;) will be allocated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - AC/S FAACT</measure>
    <time_frame>Day 1</time_frame>
    <description>Score of the 12-question AC/S module (Anorexia-Cachexia module) of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire assessing anorexia and cachexia: the AC/S module of the FAACT questionnaire consists of 12 questions to assess over the last 7 days quality of life, related to anorexia or cachexia. The score ranges between 0 and 48, the higher the score, the higher the quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Neutrophil/Lymphocyte Ratio</measure>
    <time_frame>Day 1</time_frame>
    <description>neutrophil/lymphocyte ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - CRP</measure>
    <time_frame>Day 1</time_frame>
    <description>CRP level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Fibrinogen</measure>
    <time_frame>Day 1</time_frame>
    <description>fibrinogen level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the Quality of Life Associated With the Different Stages of Cachexia.</measure>
    <time_frame>Day 1</time_frame>
    <description>Quality of life has been analysed using scores from the functional scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 items (EORTC QLQ-C30 questionnaire): score ranging from 0 (malfunction) to 100 (healthy level of functioning) for the following parameters : physical, role, cognitive, emotional and social scales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the Level of Physical Activity Associated With the Different Stages of Cachexia.</measure>
    <time_frame>Day 1</time_frame>
    <description>Three levels of physical activity are defined:&#xD;
- Low&#xD;
No activity is reported OR&#xD;
An activity is reported but does not reach moderate or high levels.&#xD;
- Moderate&#xD;
Corresponds to one of the following 3 criteria:&#xD;
3 or more days of intense activity lasting at least 20 min per day OR&#xD;
5 or more days of moderate intensity activity and / or walking for at least 30 min per day OR&#xD;
5 or more days of activity combining walking, activities of moderate or high intensity, thus achieving at least 600 MET-minutes / week&#xD;
- High&#xD;
Corresponds to one of the following 2 criteria:&#xD;
Intense activity at least 3 days a week and at least 1500 MET-minutes / week OR&#xD;
7 or more days of activity combining walking, moderate and high intensity activities, achieving at least 3000 MET-minutes / week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Receiving a Pharmacological Treatment for Cachexia or for Associated Symptoms</measure>
    <time_frame>Day 1</time_frame>
    <description>Pharmacological treatment of cachexia or associated symptoms: Yes / No</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Receiving a Non-Pharmacological Treatment for Cachexia or for Associated Symptoms</measure>
    <time_frame>Day 1</time_frame>
    <description>Non-pharmacological treatment of cachexia or associated symptoms: Y/N</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Receiving Systemic Corticosteroids, Anti-inflammatory Drugs, Omega 3 Fatty Acids Treatments</measure>
    <time_frame>Day 1</time_frame>
    <description>Treatments with systemic corticosteroids, anti-inflammatory drugs, Omega 3 fatty acids: Yes/No</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Diabetes Treatments</measure>
    <time_frame>Day 1</time_frame>
    <description>Diabetes treatments : Yes/No</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Cachexia</measure>
    <time_frame>Day 1</time_frame>
    <description>Proportion of patients with cachexia according to the subjective assessment of the clinician&#xD;
Proportion of patients with cachexia according to the Fearon criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Anorexia</measure>
    <time_frame>Day 1</time_frame>
    <description>Proportion of patients with anorexia according to the subjective assessment of the clinician&#xD;
Proportion of patients with anorexia according to the Ingesta VAS&#xD;
Proportion of patients with anorexia according to the AC/S-FAACT module score&#xD;
Proportion of patients with anorexia according to question 13 of the QLQ-C30 questionnaire: &quot;Have you had a lack of appetite?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Malnutrition</measure>
    <time_frame>Day 1</time_frame>
    <description>Proportion of patients with severe malnutrition according to the subjective assessment of the clinician&#xD;
Proportion of patients with severe malnutrition according to the malnutrition criteria defined by the HAS.</description>
  </secondary_outcome>
  <enrollment type="Actual">539</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <condition>Cachexia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with non-small cell lung cancer (NSCLC) from outpatient visit, Day Hospital or&#xD;
        in-patient hospitalization.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient 18 years of age and older&#xD;
&#xD;
          -  Patient with NSCLC&#xD;
&#xD;
          -  Patient who has been informed of the study and who has signed a patient information&#xD;
             leaflet for France or an informed consent for Belgium&#xD;
&#xD;
          -  Patient able to complete a self-assessment questionnaire&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient unable to consent and/or unable to sign the patient information form in France&#xD;
             or an informed consent in Belgium&#xD;
&#xD;
          -  Patient with a complete resection of an early stage NSCLC&#xD;
&#xD;
          -  History of head and neck cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luz Bobadilla, MD</last_name>
    <role>Study Director</role>
    <affiliation>Chugai Pharma France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chugai Pharma France</name>
      <address>
        <city>Paris</city>
        <zip>92042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.</citation>
    <PMID>21296615</PMID>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <results_first_submitted>December 18, 2017</results_first_submitted>
  <results_first_submitted_qc>March 8, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 10, 2019</results_first_posted>
  <last_update_submitted>September 12, 2019</last_update_submitted>
  <last_update_submitted_qc>September 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cachexia</keyword>
  <keyword>Non-Small Cell Lung cancer</keyword>
  <keyword>Anorexia</keyword>
  <keyword>Malnutrition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Wasting Syndrome</mesh_term>
    <mesh_term>Cachexia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>56 oncologists, lung specialists or radiation oncologists treating patients with a malignant lung tumour have recruited patients from outpatient visit, day hospital or in-patient hospitalization in France and Belgium, between the 25th of July and the 31th of October 2016. Patients were recruited in a consecutive manner.</recruitment_details>
      <pre_assignment_details>539 patients were recruited. Among them, 5 did not meet the eligibility criteria, 1 withdrew his/her consent, 2 were excluded during the data review because the cancer histology was undefined.&#xD;
The analysis population included 531 patients and among them 312 had skeletal muscle mass assessment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>NSCLC Patient</title>
          <description>Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="539"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="531">This cross-sectional study had only 1 visit.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The baseline analysis population is composed of all included patients without major protocol deviation.</population>
      <group_list>
        <group group_id="B1">
          <title>NSCLC Patient</title>
          <description>Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="531"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="531"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.2" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="531"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="178"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="353"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Performance Status ECOG (Eastern Cooperative Oncology Group)</title>
          <description>Evaluated by the Investigator during the patient visit (4=worst outcome) :&#xD;
0 Fully active - Able to carry on all pre-disease performance without restriction.&#xD;
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature&#xD;
Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.&#xD;
Capable of only limited self-care. Confined to bed or chair more than 50% of waking hours.&#xD;
Completely disabled. Cannot carry on any self-care; totally confined to bed or chair.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="531"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="531"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="300"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="531"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="531"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="531"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="531"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Non smoker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Past smoker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="359"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Current smoker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="97"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Histology type</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="531"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Squamous cell carcinoma</title>
                  <measurement_list>
                    <measurement group_id="B1" value="140"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Adenocarcinoma</title>
                  <measurement_list>
                    <measurement group_id="B1" value="348"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Large cell carcinoma</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Others</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Molecular abnormalities</title>
          <population>Missing data for 202 patients</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="329"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>EGFR, ALK, ROS1, BRAF or HER2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>K-RAS</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="B1" value="214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tumor stages</title>
          <description>TNM stage at the time of the visit was collected by the Investigator and classified as follow:&#xD;
Stage 0: (Tis N0 M0)&#xD;
Stage I - II: (T1a /T1b N0 M0) (T2a N0 M0) (T1a/T1b N1 M0 - T2a N1 M0 - T2b N0 M0) (T2b N1 M0 - T3 N0 M0)&#xD;
Stage III A: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)&#xD;
Stade III B - IV : (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)</description>
          <population>Missing data for 27 patients</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="504"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Stage I-II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Stage IIIA</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Stage IIIB-IV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="440"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown stage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Frequency of Cachexia According to Modified Fearon Criteria</title>
        <description>Percentage of NSCLC patients with a cachexia according to Fearon criteria modified for the stages of pre-cachexia and refractory cachexia in order to classify all the featured cases without ambiguity.&#xD;
A patient was considered to have cachexia if he/she had:&#xD;
Weight loss &gt;5% in the last 6 months prior to inclusion or&#xD;
BMI &lt;20 kg/m² and weight loss between 2 and 5% in the 6 months prior to inclusion or&#xD;
Weight loss &gt;2% and sarcopenia (as evaluated by the muscle mass index at L3) if available. If data were not available regarding possible sarcopenia, the presence of cachexia was assigned based on the 2 above conditions.&#xD;
In the 3 cases defined above, patient should not have entered the refractory cachexia stage, which was defined as: ECOG performance score of 3 or 4 and a low survival expectancy as defined by Martin et al. (J Clin Oncol 2015) (BMI &lt;20 kg/m² and weight loss ≥ 6%) or (20 ≤ BMI ≤ 21.9 kg/m² and weight loss ≥ 11%) or (22 kg/m² ≤ BMI and weight loss ≥ 15%).</description>
        <time_frame>Day1</time_frame>
        <population>missing data for 84 patients</population>
        <group_list>
          <group group_id="O1">
            <title>NSCLC Patients With Cachexia</title>
            <description>Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line with a cachexia</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Cachexia According to Modified Fearon Criteria</title>
          <description>Percentage of NSCLC patients with a cachexia according to Fearon criteria modified for the stages of pre-cachexia and refractory cachexia in order to classify all the featured cases without ambiguity.&#xD;
A patient was considered to have cachexia if he/she had:&#xD;
Weight loss &gt;5% in the last 6 months prior to inclusion or&#xD;
BMI &lt;20 kg/m² and weight loss between 2 and 5% in the 6 months prior to inclusion or&#xD;
Weight loss &gt;2% and sarcopenia (as evaluated by the muscle mass index at L3) if available. If data were not available regarding possible sarcopenia, the presence of cachexia was assigned based on the 2 above conditions.&#xD;
In the 3 cases defined above, patient should not have entered the refractory cachexia stage, which was defined as: ECOG performance score of 3 or 4 and a low survival expectancy as defined by Martin et al. (J Clin Oncol 2015) (BMI &lt;20 kg/m² and weight loss ≥ 6%) or (20 ≤ BMI ≤ 21.9 kg/m² and weight loss ≥ 11%) or (22 kg/m² ≤ BMI and weight loss ≥ 15%).</description>
          <population>missing data for 84 patients</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="447"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="173"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of the Different Stages of Cachexia in the General NSCLC Population</title>
        <description>Percentage of the different stages of cachexia at inclusion.&#xD;
The different stages of cachexia used the following classification:&#xD;
No Cachexia: 1) no weight loss (WL&lt;2%) or 2) weight gain AND no anorexia AND no sarcopenia&#xD;
The pre-cachexia stage : 1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss &lt; 2% AND sarcopenia&#xD;
Cachexia: 1) Weight loss &gt; 5% OR 2) weight loss between 2 and 5% AND BMI &lt; 20 kg/m² OR 3) weight loss &gt; 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage&#xD;
Refractory cachexia: ECOG 3 or 4 AND low survival expectancy [BMI &lt; 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]</description>
        <time_frame>Day 1</time_frame>
        <population>Missing data for 84 patients</population>
        <group_list>
          <group group_id="O1">
            <title>NSCLC Patients</title>
            <description>Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) regardless of the tumor stage and the treatment line</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of the Different Stages of Cachexia in the General NSCLC Population</title>
          <description>Percentage of the different stages of cachexia at inclusion.&#xD;
The different stages of cachexia used the following classification:&#xD;
No Cachexia: 1) no weight loss (WL&lt;2%) or 2) weight gain AND no anorexia AND no sarcopenia&#xD;
The pre-cachexia stage : 1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss &lt; 2% AND sarcopenia&#xD;
Cachexia: 1) Weight loss &gt; 5% OR 2) weight loss between 2 and 5% AND BMI &lt; 20 kg/m² OR 3) weight loss &gt; 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage&#xD;
Refractory cachexia: ECOG 3 or 4 AND low survival expectancy [BMI &lt; 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]</description>
          <population>Missing data for 84 patients</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="447"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="119"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pre-Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="151"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="173"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Refractory Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Stage Associated With NSCLC.</title>
        <description>Percentage of the different stages of cachexia at inclusion according to the NSCLC stage</description>
        <time_frame>Day 1</time_frame>
        <population>Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) Missing data for 81 patients</population>
        <group_list>
          <group group_id="O1">
            <title>Cancer Stage I-II</title>
            <description>Patients with one of the following TNMs at the time of the visit: (T1a /T1b N0 M0) (T2a N0 M0) (T1a/T1b N1 M0 - T2a N1 M0 - T2b N0 M0) (T2b N1 M0 - T3 N0 M0)</description>
          </group>
          <group group_id="O2">
            <title>Cancer Stage IIIA</title>
            <description>Patients with one of the following TNMs at the time of the visit: (T1/T2 N2 M0 - T3 N1/N2 M0 - T4 N0/N1 M0)</description>
          </group>
          <group group_id="O3">
            <title>Cancer Stage IIIB- IV</title>
            <description>Patients with one of the following TNMs at the time of the visit: (T4 N2 M0 - T1/T2/T3/T4 N3 M0) (T1/T2/T3/T4 N0/N1/N2/N3 M1A/M1 with at least 1 lung/pleura or lymph node metastasis) (T1/T2/T3/T4 N0/N1/N2/N3 M1B/M1 with at least 1 metastasis other than lung/pleura or lymph node metastasis)</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Stage Associated With NSCLC.</title>
          <description>Percentage of the different stages of cachexia at inclusion according to the NSCLC stage</description>
          <population>Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) Missing data for 81 patients</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="370"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="95"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pre-Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="124"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="148"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Refractory Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Histology Associated With NSCLC.</title>
        <description>Percentage of the different stages of cachexia according to the NSCLC histology</description>
        <time_frame>Day 1</time_frame>
        <population>Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) Missing data for 84 patients</population>
        <group_list>
          <group group_id="O1">
            <title>Squamous Cell Carcinoma</title>
            <description>Patients with squamous cell carcinoma</description>
          </group>
          <group group_id="O2">
            <title>Adenocarcinoma</title>
            <description>Patients with adenocarcinoma</description>
          </group>
          <group group_id="O3">
            <title>Large Cell Carcinoma and Other Histology Type</title>
            <description>Patients with large cell carcinoma and other histology type</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Histology Associated With NSCLC.</title>
          <description>Percentage of the different stages of cachexia according to the NSCLC histology</description>
          <population>Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) Missing data for 84 patients</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="116"/>
                <count group_id="O2" value="296"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="79"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pre-Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="98"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="115"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Refractory Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Sarcopenia in the General NSCLC Patients With Cachexia</title>
        <description>Percentage of patients with sarcopenia in the general NSCLC patients with cachexia</description>
        <time_frame>Day 1</time_frame>
        <population>Population with no missing data for the 3 interest criteria defining the cachexia</population>
        <group_list>
          <group group_id="O1">
            <title>Cachexia NSCLC Patients</title>
            <description>A patient was considered to have cachexia if he/she had:&#xD;
Weight loss &gt;5% in the last 6 months prior to inclusion or&#xD;
BMI &lt;20 kg/m² and weight loss between 2 and 5% in the 6 months prior to inclusion or&#xD;
Weight loss &gt;2% and sarcopenia (as evaluated by the muscle mass index at L3) if available. If data were not available regarding possible sarcopenia, the presence of cachexia was assigned based on the 2 above conditions.&#xD;
In the 3 cases defined above, patient should not have entered the refractory cachexia stage, which was defined as: ECOG performance score of 3 or 4 and a low survival expectancy as defined by Martin et al. (J Clin Oncol 2015) (BMI &lt;20 kg/m² and weight loss ≥ 6%) or (20 ≤ BMI ≤ 21.9 kg/m² and weight loss ≥ 11%) or (22 kg/m² ≤ BMI and weight loss ≥ 15%).</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Sarcopenia in the General NSCLC Patients With Cachexia</title>
          <description>Percentage of patients with sarcopenia in the general NSCLC patients with cachexia</description>
          <population>Population with no missing data for the 3 interest criteria defining the cachexia</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Sarcopenia With no Clinical Significant Weight Loss in the General NSCLC Patients With Pre-cachexia</title>
        <description>Percentage of patient with sarcopenia and no clinical significant weight loss (sarcopenia and WL&lt; 2%) in the general NSCLC patients with pre-cachexia:</description>
        <time_frame>Day 1</time_frame>
        <population>Population with no missing data for the 3 interest criteria defining the pre-cachexia</population>
        <group_list>
          <group group_id="O1">
            <title>Pre-Cachexia NSCLC Patients</title>
            <description>Pre-cachexia was defined as:&#xD;
2% ≤ weight loss (WL) ≤ 5% and BMI ≥ 20 kg/m² or&#xD;
anorexia or&#xD;
sarcopenia and WL&lt; 2%</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Sarcopenia With no Clinical Significant Weight Loss in the General NSCLC Patients With Pre-cachexia</title>
          <description>Percentage of patient with sarcopenia and no clinical significant weight loss (sarcopenia and WL&lt; 2%) in the general NSCLC patients with pre-cachexia:</description>
          <population>Population with no missing data for the 3 interest criteria defining the pre-cachexia</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC.</title>
        <description>Percentage of the different stages of cachexia according to the molecular abnormalities associated with NSCLC:&#xD;
EGRF, ALK, ROS1, BRAF or HER2&#xD;
K-RAS&#xD;
No mutation</description>
        <time_frame>Day 1</time_frame>
        <population>NSCLC patients Overall number of patients analyzed for cachexia stage; 244 missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>EGFR, ALK, ROS1, BRAF or HER2</title>
            <description>NSCLC patients with at least one of the following molecular abnormalities : EGFR, ALK, ROS1, BRAF or HER2</description>
          </group>
          <group group_id="O2">
            <title>K-RAS</title>
            <description>NSCLC patients with a K-RAS molecular abnormality</description>
          </group>
          <group group_id="O3">
            <title>No Mutation</title>
            <description>NSCLC patients with no mutation</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC.</title>
          <description>Percentage of the different stages of cachexia according to the molecular abnormalities associated with NSCLC:&#xD;
EGRF, ALK, ROS1, BRAF or HER2&#xD;
K-RAS&#xD;
No mutation</description>
          <population>NSCLC patients Overall number of patients analyzed for cachexia stage; 244 missing data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="58"/>
                <count group_id="O3" value="183"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pre-Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="79"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Refractory Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis applies to all rows and columns.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0032</p_value>
            <method>likelihood-ratio test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical Analysis 2 for Frequency of the Different Stages of Cachexia, excluding the refractory cachexia stage, in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC.&#xD;
Statistical analysis applies to all rows and columns.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0008</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of the Different Stages of Cachexia According to the Number of Treatments Received.</title>
        <description>NSCLC patients. 84 patients with missing data</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>no NSCLC Treatment</title>
            <description>Patient with no cancer treatment received for NSCLC</description>
          </group>
          <group group_id="O2">
            <title>1 NSCLC Treatment</title>
            <description>Patient with 1 cancer treatment received for NSCLC</description>
          </group>
          <group group_id="O3">
            <title>2 NSCLC Treatments</title>
            <description>Patient with 2 cancer treatments received for NSCLC</description>
          </group>
          <group group_id="O4">
            <title>3 NSCLC Treatments</title>
            <description>Patient with 3 cancer treatments received for NSCLC</description>
          </group>
          <group group_id="O5">
            <title>at Least 4 NSCLC Treatments</title>
            <description>Patient with at least 4 cancer treatments received for NSCLC</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of the Different Stages of Cachexia According to the Number of Treatments Received.</title>
          <description>NSCLC patients. 84 patients with missing data</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="82"/>
                <count group_id="O3" value="137"/>
                <count group_id="O4" value="79"/>
                <count group_id="O5" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="42"/>
                    <measurement group_id="O4" value="26"/>
                    <measurement group_id="O5" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pre-Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="42"/>
                    <measurement group_id="O4" value="22"/>
                    <measurement group_id="O5" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="50"/>
                    <measurement group_id="O4" value="31"/>
                    <measurement group_id="O5" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Refractory Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of the Different Stages of Cachexia According to the Types of Treatments Received.</title>
        <description>Stage of cachexia at inclusion according to the type of treatments received (surgery, radiotherapy, chemotherapy, targeted therapies).</description>
        <time_frame>Day 1</time_frame>
        <population>NSCLC patients. 101 missing data</population>
        <group_list>
          <group group_id="O1">
            <title>Surgery</title>
            <description>Patient who had at least 1 surgery for NSCLC treatment</description>
          </group>
          <group group_id="O2">
            <title>Radioterapy</title>
            <description>Patient who received at least 1 radiotherapy for NSCLC treatment</description>
          </group>
          <group group_id="O3">
            <title>Chemotherapy</title>
            <description>Patient who received at least 1 chemotherapy for NSCLC treatment</description>
          </group>
          <group group_id="O4">
            <title>Targeted Therapy</title>
            <description>Patient with at least 1 targeted therapy received for NSCLC</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of the Different Stages of Cachexia According to the Types of Treatments Received.</title>
          <description>Stage of cachexia at inclusion according to the type of treatments received (surgery, radiotherapy, chemotherapy, targeted therapies).</description>
          <population>NSCLC patients. 101 missing data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="133"/>
                <count group_id="O3" value="378"/>
                <count group_id="O4" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="42"/>
                    <measurement group_id="O3" value="107"/>
                    <measurement group_id="O4" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pre-Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="50"/>
                    <measurement group_id="O3" value="121"/>
                    <measurement group_id="O4" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="40"/>
                    <measurement group_id="O3" value="146"/>
                    <measurement group_id="O4" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Refractory Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Nutritional State</title>
        <description>• Nutritional state according to the different stages of cachexia The variables used will be: serum albumin levels, serum pre-albumin levels, BMI and weight.</description>
        <time_frame>Day 1</time_frame>
        <population>NSCLC patients</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Loss &gt;=15%</title>
            <description>Patients with weight loss at inclusion &gt;=15% of the weight 6 months prior to inclusion.</description>
          </group>
          <group group_id="O2">
            <title>Weight Loss &gt;=10%</title>
            <description>Patients with weight loss at inclusion &gt;=10% of the weight 6 months prior to inclusion.</description>
          </group>
          <group group_id="O3">
            <title>Albuminemia &lt; 30-35g/L</title>
            <description>Patients with albuminemia &lt; 30g/L (patient &lt; 70 years old) or &lt; 35g/L (patient ≥ 70 years old)</description>
          </group>
          <group group_id="O4">
            <title>Pre-albuminemia &lt; 110-200 mg/L</title>
            <description>Patients with pre-albuminemia &lt; 110g/L (patient &lt; 70 years old) or &lt; 200 mg/L (patient ≥ 70 years old)</description>
          </group>
          <group group_id="O5">
            <title>BMI &lt;18.5-21 kg/m²</title>
            <description>BMI at inclusion visit &lt; 18,5 kg/m² (patient &lt; 70 years old) or &lt; 21 kg/m² (patients≥70 years old)</description>
          </group>
        </group_list>
        <measure>
          <title>Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Nutritional State</title>
          <description>• Nutritional state according to the different stages of cachexia The variables used will be: serum albumin levels, serum pre-albumin levels, BMI and weight.</description>
          <population>NSCLC patients</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="63"/>
                <count group_id="O3" value="35"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pre-Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="60"/>
                    <measurement group_id="O3" value="21"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Refractory Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Blood Glucose</title>
        <description>Blood glucose abnormalities according to the different stages of cachexia at inclusion</description>
        <time_frame>Day 1</time_frame>
        <population>NSCLC patients 329 data missing</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Blood Glucose</title>
            <description>&lt; 1g/L</description>
          </group>
          <group group_id="O2">
            <title>Moderate Blood Glucose</title>
            <description>&gt;= 1g/L &lt;= 1.26g/L</description>
          </group>
          <group group_id="O3">
            <title>High Blood Glucose</title>
            <description>&gt;1.26g/L</description>
          </group>
        </group_list>
        <measure>
          <title>Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Blood Glucose</title>
          <description>Blood glucose abnormalities according to the different stages of cachexia at inclusion</description>
          <population>NSCLC patients 329 data missing</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="36"/>
                <count group_id="O3" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pre-cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Refractory cachexia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - Dietary Intake Visual Analog Scale</title>
        <description>Dietary Intake Visual Analog Scale (Dietary intake VAS): The question &quot;Could you indicate the amount you currently eat, placing a vertical mark on the line between &quot;nothing at all&quot; and &quot;as usual&quot;? &quot;. Depending on the location of the patient mark on the scale, a score of between 0 (&quot;nothing at all&quot;) and 10 (&quot;as usual&quot;) will be allocated.</description>
        <time_frame>Day 1</time_frame>
        <population>NSCLC patients 12 missing data</population>
        <group_list>
          <group group_id="O1">
            <title>No Cachexia</title>
            <description>1) no weight loss (WL&lt;2%) or 2) weight gain AND no anorexia AND no sarcopenia</description>
          </group>
          <group group_id="O2">
            <title>Pre-cachexia</title>
            <description>1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss &lt; 2% AND sarcopenia</description>
          </group>
          <group group_id="O3">
            <title>Cachexia</title>
            <description>1) Weight loss &gt; 5% OR 2) weight loss between 2 and 5% AND BMI &lt; 20 kg/m² OR 3) weight loss &gt; 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage</description>
          </group>
          <group group_id="O4">
            <title>Refractory Cachexia</title>
            <description>ECOG 3 or 4 AND low survival expectancy [BMI &lt; 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]</description>
          </group>
        </group_list>
        <measure>
          <title>Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - Dietary Intake Visual Analog Scale</title>
          <description>Dietary Intake Visual Analog Scale (Dietary intake VAS): The question &quot;Could you indicate the amount you currently eat, placing a vertical mark on the line between &quot;nothing at all&quot; and &quot;as usual&quot;? &quot;. Depending on the location of the patient mark on the scale, a score of between 0 (&quot;nothing at all&quot;) and 10 (&quot;as usual&quot;) will be allocated.</description>
          <population>NSCLC patients 12 missing data</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
                <count group_id="O2" value="146"/>
                <count group_id="O3" value="168"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.57" spread="1.07"/>
                    <measurement group_id="O2" value="7.68" spread="2.64"/>
                    <measurement group_id="O3" value="6.51" spread="2.89"/>
                    <measurement group_id="O4" value="3.13" spread="1.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - AC/S FAACT</title>
        <description>Score of the 12-question AC/S module (Anorexia-Cachexia module) of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire assessing anorexia and cachexia: the AC/S module of the FAACT questionnaire consists of 12 questions to assess over the last 7 days quality of life, related to anorexia or cachexia. The score ranges between 0 and 48, the higher the score, the higher the quality of life.</description>
        <time_frame>Day 1</time_frame>
        <population>NSCLC patients 9 missing data</population>
        <group_list>
          <group group_id="O1">
            <title>No Cachexia</title>
            <description>1) no weight loss (WL&lt;2%) or 2) weight gain AND no anorexia AND no sarcopenia</description>
          </group>
          <group group_id="O2">
            <title>Pre-cachexia</title>
            <description>1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss &lt; 2% AND sarcopenia</description>
          </group>
          <group group_id="O3">
            <title>Cachexia</title>
            <description>1) Weight loss &gt; 5% OR 2) weight loss between 2 and 5% AND BMI &lt; 20 kg/m² OR 3) weight loss &gt; 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage</description>
          </group>
          <group group_id="O4">
            <title>Refractory Cachexia</title>
            <description>ECOG 3 or 4 AND low survival expectancy [BMI &lt; 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]</description>
          </group>
        </group_list>
        <measure>
          <title>Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - AC/S FAACT</title>
          <description>Score of the 12-question AC/S module (Anorexia-Cachexia module) of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire assessing anorexia and cachexia: the AC/S module of the FAACT questionnaire consists of 12 questions to assess over the last 7 days quality of life, related to anorexia or cachexia. The score ranges between 0 and 48, the higher the score, the higher the quality of life.</description>
          <population>NSCLC patients 9 missing data</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="119"/>
                <count group_id="O2" value="148"/>
                <count group_id="O3" value="167"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.00" spread="3.90"/>
                    <measurement group_id="O2" value="35.09" spread="7.02"/>
                    <measurement group_id="O3" value="32.60" spread="7.16"/>
                    <measurement group_id="O4" value="25.75" spread="10.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Neutrophil/Lymphocyte Ratio</title>
        <description>neutrophil/lymphocyte ratio</description>
        <time_frame>Day 1</time_frame>
        <population>NSCLC patients 112 missing data</population>
        <group_list>
          <group group_id="O1">
            <title>No Cachexia</title>
            <description>1) no weight loss (WL&lt;2%) or 2) weight gain AND no anorexia AND no sarcopenia</description>
          </group>
          <group group_id="O2">
            <title>Pre-cachexia</title>
            <description>1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss &lt; 2% AND sarcopenia</description>
          </group>
          <group group_id="O3">
            <title>Cachexia</title>
            <description>1) Weight loss &gt; 5% OR 2) weight loss between 2 and 5% AND BMI &lt; 20 kg/m² OR 3) weight loss &gt; 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage</description>
          </group>
          <group group_id="O4">
            <title>Refractory Cachexia</title>
            <description>ECOG 3 or 4 AND low survival expectancy [BMI &lt; 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]</description>
          </group>
        </group_list>
        <measure>
          <title>Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Neutrophil/Lymphocyte Ratio</title>
          <description>neutrophil/lymphocyte ratio</description>
          <population>NSCLC patients 112 missing data</population>
          <units>no unit (ratio)</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="113"/>
                <count group_id="O3" value="132"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.54" lower_limit="1.90" upper_limit="3.87"/>
                    <measurement group_id="O2" value="2.73" lower_limit="1.85" upper_limit="4.37"/>
                    <measurement group_id="O3" value="3.75" lower_limit="2.00" upper_limit="6.14"/>
                    <measurement group_id="O4" value="7.15" lower_limit="3.51" upper_limit="15.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - CRP</title>
        <description>CRP level</description>
        <time_frame>Day 1</time_frame>
        <population>NSCLC patients 317 missing data</population>
        <group_list>
          <group group_id="O1">
            <title>No Cachexia</title>
            <description>1) no weight loss (WL&lt;2%) or 2) weight gain AND no anorexia AND no sarcopenia</description>
          </group>
          <group group_id="O2">
            <title>Pre-cachexia</title>
            <description>1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss &lt; 2% AND sarcopenia</description>
          </group>
          <group group_id="O3">
            <title>Cachexia</title>
            <description>1) Weight loss &gt; 5% OR 2) weight loss between 2 and 5% AND BMI &lt; 20 kg/m² OR 3) weight loss &gt; 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage</description>
          </group>
          <group group_id="O4">
            <title>Refractory Cachexia</title>
            <description>ECOG 3 or 4 AND low survival expectancy [BMI &lt; 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]</description>
          </group>
        </group_list>
        <measure>
          <title>Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - CRP</title>
          <description>CRP level</description>
          <population>NSCLC patients 317 missing data</population>
          <units>mg/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="64"/>
                <count group_id="O4" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18" lower_limit="5.60" upper_limit="30.10"/>
                    <measurement group_id="O2" value="7" lower_limit="3.00" upper_limit="25.00"/>
                    <measurement group_id="O3" value="21.5" lower_limit="7.85" upper_limit="53.00"/>
                    <measurement group_id="O4" value="16.5" lower_limit="15.00" upper_limit="18.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Fibrinogen</title>
        <description>fibrinogen level</description>
        <time_frame>Day 1</time_frame>
        <population>NSCLC patients 387 missing data</population>
        <group_list>
          <group group_id="O1">
            <title>No Cachexia</title>
            <description>1) no weight loss (WL&lt;2%) or 2) weight gain AND no anorexia AND no sarcopenia</description>
          </group>
          <group group_id="O2">
            <title>Pre-cachexia</title>
            <description>1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss &lt; 2% AND sarcopenia</description>
          </group>
          <group group_id="O3">
            <title>Cachexia</title>
            <description>1) Weight loss &gt; 5% OR 2) weight loss between 2 and 5% AND BMI &lt; 20 kg/m² OR 3) weight loss &gt; 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage</description>
          </group>
          <group group_id="O4">
            <title>Refractory Cachexia</title>
            <description>ECOG 3 or 4 AND low survival expectancy [BMI &lt; 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]</description>
          </group>
        </group_list>
        <measure>
          <title>Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Fibrinogen</title>
          <description>fibrinogen level</description>
          <population>NSCLC patients 387 missing data</population>
          <units>g/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.58" lower_limit="3.93" upper_limit="5.30"/>
                    <measurement group_id="O2" value="4.75" lower_limit="3.90" upper_limit="5.90"/>
                    <measurement group_id="O3" value="4.96" lower_limit="4.50" upper_limit="6.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Description of the Quality of Life Associated With the Different Stages of Cachexia.</title>
        <description>Quality of life has been analysed using scores from the functional scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 items (EORTC QLQ-C30 questionnaire): score ranging from 0 (malfunction) to 100 (healthy level of functioning) for the following parameters : physical, role, cognitive, emotional and social scales</description>
        <time_frame>Day 1</time_frame>
        <population>NSCLC patients Physical scale: 16 missing data Role scale: 17 missing data Cognitive scale: 16 missing data Emotional scale: 16 missing data Social scale: 18 missing data</population>
        <group_list>
          <group group_id="O1">
            <title>Physical Scale</title>
            <description>score ranging from 0 (malfunction) to 100 (healthy level of functioning)</description>
          </group>
          <group group_id="O2">
            <title>Role Scale</title>
            <description>score ranging from 0 (malfunction) to 100 (healthy level of functioning)</description>
          </group>
          <group group_id="O3">
            <title>Cognitive Scale</title>
            <description>score ranging from 0 (malfunction) to 100 (healthy level of functioning)</description>
          </group>
          <group group_id="O4">
            <title>Emotional Scale</title>
            <description>score ranging from 0 (malfunction) to 100 (healthy level of functioning)</description>
          </group>
          <group group_id="O5">
            <title>Social Scale</title>
            <description>score ranging from 0 (malfunction) to 100 (healthy level of functioning)</description>
          </group>
        </group_list>
        <measure>
          <title>Description of the Quality of Life Associated With the Different Stages of Cachexia.</title>
          <description>Quality of life has been analysed using scores from the functional scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 items (EORTC QLQ-C30 questionnaire): score ranging from 0 (malfunction) to 100 (healthy level of functioning) for the following parameters : physical, role, cognitive, emotional and social scales</description>
          <population>NSCLC patients Physical scale: 16 missing data Role scale: 17 missing data Cognitive scale: 16 missing data Emotional scale: 16 missing data Social scale: 18 missing data</population>
          <units>Scale score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="431"/>
                <count group_id="O2" value="430"/>
                <count group_id="O3" value="431"/>
                <count group_id="O4" value="431"/>
                <count group_id="O5" value="429"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No Cachexia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="119"/>
                    <count group_id="O2" value="119"/>
                    <count group_id="O3" value="118"/>
                    <count group_id="O4" value="118"/>
                    <count group_id="O5" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.6" spread="20.1"/>
                    <measurement group_id="O2" value="77.6" spread="26.9"/>
                    <measurement group_id="O3" value="84.5" spread="21.0"/>
                    <measurement group_id="O4" value="82.0" spread="18.2"/>
                    <measurement group_id="O5" value="84.9" spread="21.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-Cachexia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="146"/>
                    <count group_id="O3" value="145"/>
                    <count group_id="O4" value="145"/>
                    <count group_id="O5" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.0" spread="21.4"/>
                    <measurement group_id="O2" value="62.6" spread="32.5"/>
                    <measurement group_id="O3" value="79.7" spread="23.4"/>
                    <measurement group_id="O4" value="71.5" spread="25.1"/>
                    <measurement group_id="O5" value="72.0" spread="28.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cachexia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="162"/>
                    <count group_id="O2" value="161"/>
                    <count group_id="O3" value="164"/>
                    <count group_id="O4" value="164"/>
                    <count group_id="O5" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.8" spread="24.5"/>
                    <measurement group_id="O2" value="56.2" spread="35.5"/>
                    <measurement group_id="O3" value="79.1" spread="22.3"/>
                    <measurement group_id="O4" value="68.1" spread="24.8"/>
                    <measurement group_id="O5" value="67.8" spread="31.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Refractory Cachexia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="4"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.3" spread="9.4"/>
                    <measurement group_id="O2" value="0.0" spread="0.0"/>
                    <measurement group_id="O3" value="83.3" spread="19.2"/>
                    <measurement group_id="O4" value="45.8" spread="35.0"/>
                    <measurement group_id="O5" value="12.5" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis compares all cachexia stages.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis compares all cachexia stages.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Without refractory cachexia</p_value_desc>
            <method>Kruskal-Wallis</method>
            <method_desc>Without refractory cachexia</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis compares all cachexia stages.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis compares all cachexia stages.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Without refractory cachexia</p_value_desc>
            <method>Kruskal-Wallis</method>
            <method_desc>Without refractory cachexia</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis compares all cachexia stages.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1085</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis compares all cachexia stages.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0482</p_value>
            <p_value_desc>Without refractory cachexia</p_value_desc>
            <method>Kruskal-Wallis</method>
            <method_desc>Without refractory cachexia</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis compares all cachexia stages.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis compares all cachexia stages.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Without refractory cachexia</p_value_desc>
            <method>Kruskal-Wallis</method>
            <method_desc>Without refractory cachexia</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis compares all cachexia stages.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis compares all cachexia stages.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Without refractory cachexia</p_value_desc>
            <method>Kruskal-Wallis</method>
            <method_desc>Without refractory cachexia</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Description of the Level of Physical Activity Associated With the Different Stages of Cachexia.</title>
        <description>Three levels of physical activity are defined:&#xD;
- Low&#xD;
No activity is reported OR&#xD;
An activity is reported but does not reach moderate or high levels.&#xD;
- Moderate&#xD;
Corresponds to one of the following 3 criteria:&#xD;
3 or more days of intense activity lasting at least 20 min per day OR&#xD;
5 or more days of moderate intensity activity and / or walking for at least 30 min per day OR&#xD;
5 or more days of activity combining walking, activities of moderate or high intensity, thus achieving at least 600 MET-minutes / week&#xD;
- High&#xD;
Corresponds to one of the following 2 criteria:&#xD;
Intense activity at least 3 days a week and at least 1500 MET-minutes / week OR&#xD;
7 or more days of activity combining walking, moderate and high intensity activities, achieving at least 3000 MET-minutes / week</description>
        <time_frame>Day 1</time_frame>
        <population>NSCLC patients 69 missing data</population>
        <group_list>
          <group group_id="O1">
            <title>No Cachexia</title>
            <description>1) no weight loss (WL&lt;2%) or 2) weight gain AND no anorexia AND no sarcopenia</description>
          </group>
          <group group_id="O2">
            <title>Pre-cachexia</title>
            <description>1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss &lt; 2% AND sarcopenia</description>
          </group>
          <group group_id="O3">
            <title>Cachexia</title>
            <description>1) Weight loss &gt; 5% OR 2) weight loss between 2 and 5% AND BMI &lt; 20 kg/m² OR 3) weight loss &gt; 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage</description>
          </group>
          <group group_id="O4">
            <title>Refractory Cachexia</title>
            <description>ECOG 3 or 4 AND low survival expectancy [BMI &lt; 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]</description>
          </group>
        </group_list>
        <measure>
          <title>Description of the Level of Physical Activity Associated With the Different Stages of Cachexia.</title>
          <description>Three levels of physical activity are defined:&#xD;
- Low&#xD;
No activity is reported OR&#xD;
An activity is reported but does not reach moderate or high levels.&#xD;
- Moderate&#xD;
Corresponds to one of the following 3 criteria:&#xD;
3 or more days of intense activity lasting at least 20 min per day OR&#xD;
5 or more days of moderate intensity activity and / or walking for at least 30 min per day OR&#xD;
5 or more days of activity combining walking, activities of moderate or high intensity, thus achieving at least 600 MET-minutes / week&#xD;
- High&#xD;
Corresponds to one of the following 2 criteria:&#xD;
Intense activity at least 3 days a week and at least 1500 MET-minutes / week OR&#xD;
7 or more days of activity combining walking, moderate and high intensity activities, achieving at least 3000 MET-minutes / week</description>
          <population>NSCLC patients 69 missing data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="128"/>
                <count group_id="O3" value="144"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="56"/>
                    <measurement group_id="O3" value="78"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="42"/>
                    <measurement group_id="O3" value="39"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High</title>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="27"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Receiving a Pharmacological Treatment for Cachexia or for Associated Symptoms</title>
        <description>Pharmacological treatment of cachexia or associated symptoms: Yes / No</description>
        <time_frame>Day 1</time_frame>
        <population>NSCLC patients 225 missing data</population>
        <group_list>
          <group group_id="O1">
            <title>No Cachexia</title>
            <description>1) no weight loss (WL&lt;2%) or 2) weight gain AND no anorexia AND no sarcopenia</description>
          </group>
          <group group_id="O2">
            <title>Pre-cachexia</title>
            <description>1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss &lt; 2% AND sarcopenia</description>
          </group>
          <group group_id="O3">
            <title>Cachexia</title>
            <description>1) Weight loss &gt; 5% OR 2) weight loss between 2 and 5% AND BMI &lt; 20 kg/m² OR 3) weight loss &gt; 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage</description>
          </group>
          <group group_id="O4">
            <title>Refractory Cachexia</title>
            <description>ECOG 3 or 4 AND low survival expectancy [BMI &lt; 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Receiving a Pharmacological Treatment for Cachexia or for Associated Symptoms</title>
          <description>Pharmacological treatment of cachexia or associated symptoms: Yes / No</description>
          <population>NSCLC patients 225 missing data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="69"/>
                <count group_id="O3" value="103"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Receiving a Non-Pharmacological Treatment for Cachexia or for Associated Symptoms</title>
        <description>Non-pharmacological treatment of cachexia or associated symptoms: Y/N</description>
        <time_frame>Day 1</time_frame>
        <population>NLSCS patients with a nutritional consultation within 2 months before inclusion&#xD;
1 missing data</population>
        <group_list>
          <group group_id="O1">
            <title>No Cachexia</title>
            <description>1) no weight loss (WL&lt;2%) or 2) weight gain AND no anorexia AND no sarcopenia</description>
          </group>
          <group group_id="O2">
            <title>Pre-cachexia</title>
            <description>1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss &lt; 2% AND sarcopenia</description>
          </group>
          <group group_id="O3">
            <title>Cachexia</title>
            <description>1) Weight loss &gt; 5% OR 2) weight loss between 2 and 5% AND BMI &lt; 20 kg/m² OR 3) weight loss &gt; 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage</description>
          </group>
          <group group_id="O4">
            <title>Refractory Cachexia</title>
            <description>ECOG 3 or 4 AND low survival expectancy [BMI &lt; 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Receiving a Non-Pharmacological Treatment for Cachexia or for Associated Symptoms</title>
          <description>Non-pharmacological treatment of cachexia or associated symptoms: Y/N</description>
          <population>NLSCS patients with a nutritional consultation within 2 months before inclusion&#xD;
1 missing data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="42"/>
                <count group_id="O3" value="80"/>
                <count group_id="O4" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="41"/>
                    <measurement group_id="O3" value="77"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Receiving Systemic Corticosteroids, Anti-inflammatory Drugs, Omega 3 Fatty Acids Treatments</title>
        <description>Treatments with systemic corticosteroids, anti-inflammatory drugs, Omega 3 fatty acids: Yes/No</description>
        <time_frame>Day 1</time_frame>
        <population>NSCLC patients 11 missing data</population>
        <group_list>
          <group group_id="O1">
            <title>No Cachexia</title>
            <description>1) no weight loss (WL&lt;2%) or 2) weight gain AND no anorexia AND no sarcopenia</description>
          </group>
          <group group_id="O2">
            <title>Pre-cachexia</title>
            <description>1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss &lt; 2% AND sarcopenia</description>
          </group>
          <group group_id="O3">
            <title>Cachexia</title>
            <description>1) Weight loss &gt; 5% OR 2) weight loss between 2 and 5% AND BMI &lt; 20 kg/m² OR 3) weight loss &gt; 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage</description>
          </group>
          <group group_id="O4">
            <title>Refractory Cachexia</title>
            <description>ECOG 3 or 4 AND low survival expectancy [BMI &lt; 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Receiving Systemic Corticosteroids, Anti-inflammatory Drugs, Omega 3 Fatty Acids Treatments</title>
          <description>Treatments with systemic corticosteroids, anti-inflammatory drugs, Omega 3 fatty acids: Yes/No</description>
          <population>NSCLC patients 11 missing data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="148"/>
                <count group_id="O3" value="166"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="60"/>
                    <measurement group_id="O3" value="76"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Diabetes Treatments</title>
        <description>Diabetes treatments : Yes/No</description>
        <time_frame>Day 1</time_frame>
        <population>NSCLC patients 6 missing data</population>
        <group_list>
          <group group_id="O1">
            <title>No Cachexia</title>
            <description>1) no weight loss (WL&lt;2%) or 2) weight gain AND no anorexia AND no sarcopenia</description>
          </group>
          <group group_id="O2">
            <title>Pre-cachexia</title>
            <description>1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss &lt; 2% AND sarcopenia</description>
          </group>
          <group group_id="O3">
            <title>Cachexia</title>
            <description>1) Weight loss &gt; 5% OR 2) weight loss between 2 and 5% AND BMI &lt; 20 kg/m² OR 3) weight loss &gt; 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage</description>
          </group>
          <group group_id="O4">
            <title>Refractory Cachexia</title>
            <description>ECOG 3 or 4 AND low survival expectancy [BMI &lt; 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Diabetes Treatments</title>
          <description>Diabetes treatments : Yes/No</description>
          <population>NSCLC patients 6 missing data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
                <count group_id="O2" value="151"/>
                <count group_id="O3" value="169"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Cachexia</title>
        <description>Proportion of patients with cachexia according to the subjective assessment of the clinician&#xD;
Proportion of patients with cachexia according to the Fearon criteria</description>
        <time_frame>Day 1</time_frame>
        <population>NSCLC patients Cachexia according to Investigator: 4 missing data Cachexia according to Fearon criteria: 84 missing data</population>
        <group_list>
          <group group_id="O1">
            <title>Cachexia According to Investigator</title>
            <description>Patients with cachexia according to the subjective assessment of the clinician</description>
          </group>
          <group group_id="O2">
            <title>Cachexia According to Fearon Criteria</title>
            <description>1) Weight loss &gt; 5% OR 2) weight loss between 2 and 5% AND BMI &lt; 20 kg/m² OR 3) weight loss &gt; 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Cachexia</title>
          <description>Proportion of patients with cachexia according to the subjective assessment of the clinician&#xD;
Proportion of patients with cachexia according to the Fearon criteria</description>
          <population>NSCLC patients Cachexia according to Investigator: 4 missing data Cachexia according to Fearon criteria: 84 missing data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="527"/>
                <count group_id="O2" value="447"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="173"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Anorexia</title>
        <description>Proportion of patients with anorexia according to the subjective assessment of the clinician&#xD;
Proportion of patients with anorexia according to the Ingesta VAS&#xD;
Proportion of patients with anorexia according to the AC/S-FAACT module score&#xD;
Proportion of patients with anorexia according to question 13 of the QLQ-C30 questionnaire: &quot;Have you had a lack of appetite?&quot;</description>
        <time_frame>Day 1</time_frame>
        <population>NSCLC patients Anorexia according to Investigator: 3 missing data Anorexia according to VAS: 22 missing data Anorexia according to FAACT: 19 missing data Anorexia according to question 13 of QLQ-C30 questionnaire: 33 missing data</population>
        <group_list>
          <group group_id="O1">
            <title>Anorexia According to Investigator</title>
            <description>Patients with anorexia according to the subjective assessment of the clinician</description>
          </group>
          <group group_id="O2">
            <title>Anorexia According to VAS</title>
            <description>Patients with anorexia according to Visual analogue scale for dietary intake.: &quot;Could you indicate the amount you currently eat, placing a vertical mark on the line between &quot;nothing at all&quot; and &quot;as usual&quot;? Depending on the location of the patient mark on the scale, a score of between 0 (&quot;nothing at all&quot;) and 10 (&quot;as usual&quot;) was allocated.&#xD;
anorexia if score*100/990&lt; 70mm.</description>
          </group>
          <group group_id="O3">
            <title>Anorexia According to FAACT</title>
            <description>Patients with anorexia according to Anorexia Cachexia/Subcale (AC/S) module of the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) questionnaire: anorexia if score &lt;=37</description>
          </group>
          <group group_id="O4">
            <title>Anorexia According to Question 13 of QLQ-C30 Questionnaire</title>
            <description>Patients with anorexia according to question 13 of the QLQ-C30 questionnaire: &quot;Have you had a lack of appetite?&quot;: anorexia if answer is a A little bit, Somewhat, Quite a bit</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Anorexia</title>
          <description>Proportion of patients with anorexia according to the subjective assessment of the clinician&#xD;
Proportion of patients with anorexia according to the Ingesta VAS&#xD;
Proportion of patients with anorexia according to the AC/S-FAACT module score&#xD;
Proportion of patients with anorexia according to question 13 of the QLQ-C30 questionnaire: &quot;Have you had a lack of appetite?&quot;</description>
          <population>NSCLC patients Anorexia according to Investigator: 3 missing data Anorexia according to VAS: 22 missing data Anorexia according to FAACT: 19 missing data Anorexia according to question 13 of QLQ-C30 questionnaire: 33 missing data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="528"/>
                <count group_id="O2" value="509"/>
                <count group_id="O3" value="512"/>
                <count group_id="O4" value="498"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109"/>
                    <measurement group_id="O2" value="166"/>
                    <measurement group_id="O3" value="273"/>
                    <measurement group_id="O4" value="219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Malnutrition</title>
        <description>Proportion of patients with severe malnutrition according to the subjective assessment of the clinician&#xD;
Proportion of patients with severe malnutrition according to the malnutrition criteria defined by the HAS.</description>
        <time_frame>Day 1</time_frame>
        <population>NSCLC patients Severe malnutrition according to Investigator: 15 missing data Severe malnutrition according to the HAS: 416 missing data</population>
        <group_list>
          <group group_id="O1">
            <title>Severe Malnutrition According to Investigator</title>
            <description>Patients with severe malnutrition according to the subjective assessment of the clinician</description>
          </group>
          <group group_id="O2">
            <title>Severe Malnutrition According to the HAS</title>
            <description>Patients with malnutrition according to the Haute Autorité de Santé:&#xD;
weight loss ≥ 10%,&#xD;
BMI measured during the inclusion visit &lt;18.5 kg / m² for patients aged 70 and under and &lt;21 kg / m² for patients over 70 years of age&#xD;
Albumin &lt;30 g / L if patient &lt;70 years; or albumin &lt;35g / L if patient ≥ 70 years&#xD;
Pre-albumin &lt;110 mg / L if patient &lt;70 years</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Malnutrition</title>
          <description>Proportion of patients with severe malnutrition according to the subjective assessment of the clinician&#xD;
Proportion of patients with severe malnutrition according to the malnutrition criteria defined by the HAS.</description>
          <population>NSCLC patients Severe malnutrition according to Investigator: 15 missing data Severe malnutrition according to the HAS: 416 missing data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="516"/>
                <count group_id="O2" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>This is a non-interventional epidemiological study. No safety data was collected. No reporting of adverse reaction is expected in the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>No Safety Data Was Collected</title>
          <description>This is a non-interventional epidemiological study. No reporting of adverse reaction is expected in the study.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Study may not be published by the Health Institution or the Investigator without the prior written consent of the Promoter who has to respond as soon as possible.&#xD;
If the Investigator wishes to proceed with a publication or communication relating to the Study, the Promoter may, in the event that a serious and valid reason appears to require it, request that certain modifications be made. The modifications cannot in any way affect the scientific value of the publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Luz BOBADILLA, Medical Affairs Director</name_or_title>
      <organization>CHUGAI PHARMA FRANCE</organization>
      <phone>+33 1 56 37 05 28</phone>
      <email>bobadilla@chugai-pharm.fr</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02968979
org study id: CPF-ANA-001
nct id: NCT02968979
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to assess the frequency of cachexia and the management of
      cachexia and associated symptoms in a patient population with non-small cell lung cancer
      (NSCLC).
This is a cross-sectional, non-interventional, European (France and Belgium), multicentric
      prevalence study, conducted on a representative population of 500 patients with NSCLC, to
      assess the frequency and the management of cachexia and associated symptoms.

      The study will be conducted in accordance with the professional code of ethics and the good
      epidemiological practices guidelines developed by the ADELF (the Association of
      French-Speaking Epidemiologists) and in accordance with the STROBE recommendations for the
      drafting of reports and publications related to the study.

      The information will be collected during a single visit to the oncologist/lung specialist as
      part of the usual patient management of his/her lung cancer. The physician will explain the
      purpose of the study to the patient with an information form specific to the study and will
      inform him/her of the option to refuse or withdraw from participation. The patient
      information form in France or a specific consent form in Belgium will be signed by the
      patient and a copy will be given to him/her (the original will be kept by the physician).

      This study does not require any additional specific data. Data will come from the medical
      file and from the routine disease management. Furthermore, the following self-completion
      questionnaires will be proposed to patients: Visual analogue scale for dietary intake
      (dietary intake VAS), assessment of the concerns associated with the anorexia/cachexia
      (Anorexia-Cachexia module of the Functional Assessment of Anorexia/Cachexia Therapy [FAACT]
      questionnaire), quality of life (EORTC QLQ-C30), and assessment of physical activity (IPAQ,
      International Physical Activity Questionnaire). Abdominal CT-scan, if available, will be
      collected for assessment of skeletal muscle mass index at L3.
observational model: Cohort
time perspective: Cross-Sectional
measure: Frequency of Cachexia According to Modified Fearon Criteria
time frame: Day1
description: Percentage of NSCLC patients with a cachexia according to Fearon criteria modified for the stages of pre-cachexia and refractory cachexia in order to classify all the featured cases without ambiguity.
A patient was considered to have cachexia if he/she had:
Weight loss >5% in the last 6 months prior to inclusion or
BMI <20 kg/m² and weight loss between 2 and 5% in the 6 months prior to inclusion or
Weight loss >2% and sarcopenia (as evaluated by the muscle mass index at L3) if available. If data were not available regarding possible sarcopenia, the presence of cachexia was assigned based on the 2 above conditions.
In the 3 cases defined above, patient should not have entered the refractory cachexia stage, which was defined as: ECOG performance score of 3 or 4 and a low survival expectancy as defined by Martin et al. (J Clin Oncol 2015) (BMI <20 kg/m² and weight loss ≥ 6%) or (20 ≤ BMI ≤ 21.9 kg/m² and weight loss ≥ 11%) or (22 kg/m² ≤ BMI and weight loss ≥ 15%).
measure: Frequency of the Different Stages of Cachexia in the General NSCLC Population
time frame: Day 1
description: Percentage of the different stages of cachexia at inclusion.
The different stages of cachexia used the following classification:
No Cachexia: 1) no weight loss (WL<2%) or 2) weight gain AND no anorexia AND no sarcopenia
The pre-cachexia stage : 1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss < 2% AND sarcopenia
Cachexia: 1) Weight loss > 5% OR 2) weight loss between 2 and 5% AND BMI < 20 kg/m² OR 3) weight loss > 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage
Refractory cachexia: ECOG 3 or 4 AND low survival expectancy [BMI < 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]
measure: Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Stage Associated With NSCLC.
time frame: Day 1
description: Percentage of the different stages of cachexia at inclusion according to the NSCLC stage
measure: Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Histology Associated With NSCLC.
time frame: Day 1
description: Percentage of the different stages of cachexia according to the NSCLC histology
measure: Frequency of Sarcopenia in the General NSCLC Patients With Cachexia
time frame: Day 1
description: Percentage of patients with sarcopenia in the general NSCLC patients with cachexia
measure: Frequency of Sarcopenia With no Clinical Significant Weight Loss in the General NSCLC Patients With Pre-cachexia
time frame: Day 1
description: Percentage of patient with sarcopenia and no clinical significant weight loss (sarcopenia and WL< 2%) in the general NSCLC patients with pre-cachexia:
measure: Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC.
time frame: Day 1
description: Percentage of the different stages of cachexia according to the molecular abnormalities associated with NSCLC:
EGRF, ALK, ROS1, BRAF or HER2
K-RAS
No mutation
measure: Frequency of the Different Stages of Cachexia According to the Number of Treatments Received.
time frame: Day 1
description: NSCLC patients. 84 patients with missing data
measure: Frequency of the Different Stages of Cachexia According to the Types of Treatments Received.
time frame: Day 1
description: Stage of cachexia at inclusion according to the type of treatments received (surgery, radiotherapy, chemotherapy, targeted therapies).
measure: Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Nutritional State
time frame: Day 1
description: • Nutritional state according to the different stages of cachexia The variables used will be: serum albumin levels, serum pre-albumin levels, BMI and weight.
measure: Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Blood Glucose
time frame: Day 1
description: Blood glucose abnormalities according to the different stages of cachexia at inclusion
measure: Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - Dietary Intake Visual Analog Scale
time frame: Day 1
description: Dietary Intake Visual Analog Scale (Dietary intake VAS): The question "Could you indicate the amount you currently eat, placing a vertical mark on the line between "nothing at all" and "as usual"? ". Depending on the location of the patient mark on the scale, a score of between 0 ("nothing at all") and 10 ("as usual") will be allocated.
measure: Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - AC/S FAACT
time frame: Day 1
description: Score of the 12-question AC/S module (Anorexia-Cachexia module) of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire assessing anorexia and cachexia: the AC/S module of the FAACT questionnaire consists of 12 questions to assess over the last 7 days quality of life, related to anorexia or cachexia. The score ranges between 0 and 48, the higher the score, the higher the quality of life.
measure: Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Neutrophil/Lymphocyte Ratio
time frame: Day 1
description: neutrophil/lymphocyte ratio
measure: Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - CRP
time frame: Day 1
description: CRP level
measure: Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Fibrinogen
time frame: Day 1
description: fibrinogen level
measure: Description of the Quality of Life Associated With the Different Stages of Cachexia.
time frame: Day 1
description: Quality of life has been analysed using scores from the functional scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 items (EORTC QLQ-C30 questionnaire): score ranging from 0 (malfunction) to 100 (healthy level of functioning) for the following parameters : physical, role, cognitive, emotional and social scales
measure: Description of the Level of Physical Activity Associated With the Different Stages of Cachexia.
time frame: Day 1
description: Three levels of physical activity are defined:
- Low
No activity is reported OR
An activity is reported but does not reach moderate or high levels.
- Moderate
Corresponds to one of the following 3 criteria:
3 or more days of intense activity lasting at least 20 min per day OR
5 or more days of moderate intensity activity and / or walking for at least 30 min per day OR
5 or more days of activity combining walking, activities of moderate or high intensity, thus achieving at least 600 MET-minutes / week
- High
Corresponds to one of the following 2 criteria:
Intense activity at least 3 days a week and at least 1500 MET-minutes / week OR
7 or more days of activity combining walking, moderate and high intensity activities, achieving at least 3000 MET-minutes / week
measure: Number of Participants Receiving a Pharmacological Treatment for Cachexia or for Associated Symptoms
time frame: Day 1
description: Pharmacological treatment of cachexia or associated symptoms: Yes / No
measure: Number of Participants Receiving a Non-Pharmacological Treatment for Cachexia or for Associated Symptoms
time frame: Day 1
description: Non-pharmacological treatment of cachexia or associated symptoms: Y/N
measure: Number of Participants Receiving Systemic Corticosteroids, Anti-inflammatory Drugs, Omega 3 Fatty Acids Treatments
time frame: Day 1
description: Treatments with systemic corticosteroids, anti-inflammatory drugs, Omega 3 fatty acids: Yes/No
measure: Number of Participants With Diabetes Treatments
time frame: Day 1
description: Diabetes treatments : Yes/No
measure: Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Cachexia
time frame: Day 1
description: Proportion of patients with cachexia according to the subjective assessment of the clinician
Proportion of patients with cachexia according to the Fearon criteria
measure: Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Anorexia
time frame: Day 1
description: Proportion of patients with anorexia according to the subjective assessment of the clinician
Proportion of patients with anorexia according to the Ingesta VAS
Proportion of patients with anorexia according to the AC/S-FAACT module score
Proportion of patients with anorexia according to question 13 of the QLQ-C30 questionnaire: "Have you had a lack of appetite?"
measure: Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Malnutrition
time frame: Day 1
description: Proportion of patients with severe malnutrition according to the subjective assessment of the clinician
Proportion of patients with severe malnutrition according to the malnutrition criteria defined by the HAS.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Luz Bobadilla, MD
role: Study Director
affiliation: Chugai Pharma France
facility: 
country: France
citation: Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.
PMID: 21296615
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Wasting Syndrome
mesh term: Cachexia
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 