<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/NCT02983500</url>
  </required_header>
  <id_info>
    <org_study_id>IOM-0050346</org_study_id>
    <nct_id>NCT02983500</nct_id>
  </id_info>
  <brief_title>Patient Reported Outcomes Registry in Patient With Cancer Cachexia</brief_title>
  <acronym>PROXie</acronym>
  <official_title>Tablet-based Prospective Patient Reported Outcomes (PRO) Registry in Patients With Advanced NSCLC or Advanced Pancreatic Cancer With Focus on Cancer Cachexia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>iOMEDICO AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chugai Pharma Europe Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>iOMEDICO AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of patient reported outcomes (PRO) with tumor cachexia in a real life setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The PRO Xie project will recruit a representative cohort of patients with advanced lung or&#xD;
      advanced pancreatic cancer with a high risk for the development of cancer cachexia.&#xD;
&#xD;
      Patient Reported Outcomes (PRO) are assessed in a real life setting by a questionnaire&#xD;
      consisting of 20 questions: QoL is measured by SF12, fatigue by FACIT-F and cachexia by FAACT&#xD;
      questionnaires, respectively.&#xD;
&#xD;
      These data will determine the potential need for anti-cachexia treatment in those patients,&#xD;
      as well as the number of underweight patients, the evaluation of general QoL, fatigue and&#xD;
      cachexia and the evaluation of malnutrition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2016</start_date>
  <completion_date type="Actual">July 24, 2019</completion_date>
  <primary_completion_date type="Actual">July 24, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of patients with loss of &gt; 5 % body weight</measure>
    <time_frame>18 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of underweight patients</measure>
    <time_frame>12 months</time_frame>
    <description>BMI &lt; 20 kg/qm at start or during observation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General health-related quality of life assessment</measure>
    <time_frame>12 months</time_frame>
    <description>At baseline, throughout and at the end of the study with SF 12 questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue assessment</measure>
    <time_frame>12 months</time_frame>
    <description>At baseline, throughout and at the end of the study with FACIT-F (short version of fatigue subscale).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cachexia assessment</measure>
    <time_frame>12 months</time_frame>
    <description>At baseline, throughout and at the end of the study with FAACT (short version of anorexia / cachexia subscale).</description>
  </secondary_outcome>
  <enrollment type="Actual">253</enrollment>
  <condition>Metastatic Pancreatic Cancer</condition>
  <condition>NSCLC, Metastatic</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients diagnosed with locally advanced and unresectable or metastatic NSCLC (UICC&#xD;
        Stage IIIB/IV) or locally advanced and unresectable or metastatic pancreatic cancer (UICC&#xD;
        stage III/IV) at start of their first-line palliative systemic treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented diagnosis of NSCLC UICC stage IIIB/IV or pancreatic cancer UICC stage&#xD;
             III/IV&#xD;
&#xD;
          -  Start of the first line palliative systemic treatment&#xD;
&#xD;
          -  Ability to read and understand German&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>Manfred Welslau, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical practise for oncology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Multiple sites all over Germany</name>
      <address>
        <city>Multiple Locations</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>October 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Patient Reported Outcome (PRO)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Cachexia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02983500
org study id: IOM-0050346
nct id: NCT02983500
lead sponsor: 
collaborator: 
has dmc: No
Evaluation of patient reported outcomes (PRO) with tumor cachexia in a real life setting.
The PRO Xie project will recruit a representative cohort of patients with advanced lung or
      advanced pancreatic cancer with a high risk for the development of cancer cachexia.

      Patient Reported Outcomes (PRO) are assessed in a real life setting by a questionnaire
      consisting of 20 questions: QoL is measured by SF12, fatigue by FACIT-F and cachexia by FAACT
      questionnaires, respectively.

      These data will determine the potential need for anti-cachexia treatment in those patients,
      as well as the number of underweight patients, the evaluation of general QoL, fatigue and
      cachexia and the evaluation of malnutrition.
observational model: Cohort
time perspective: Prospective
measure: Rate of patients with loss of > 5 % body weight
time frame: 18 months
measure: Number of underweight patients
time frame: 12 months
description: BMI < 20 kg/qm at start or during observation.
measure: General health-related quality of life assessment
time frame: 12 months
description: At baseline, throughout and at the end of the study with SF 12 questionnaire.
measure: Fatigue assessment
time frame: 12 months
description: At baseline, throughout and at the end of the study with FACIT-F (short version of fatigue subscale).
measure: Cachexia assessment
time frame: 12 months
description: At baseline, throughout and at the end of the study with FAACT (short version of anorexia / cachexia subscale).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Manfred Welslau, MD
role: Principal Investigator
affiliation: Medical practise for oncology
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Cachexia
sharing ipd: No