<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/NCT03276429</url>
  </required_header>
  <id_info>
    <org_study_id>CA209-9MT</org_study_id>
    <nct_id>NCT03276429</nct_id>
  </id_info>
  <brief_title>Lung Cancer Registry for Lung Cancer Patients</brief_title>
  <acronym>LCR</acronym>
  <official_title>Development of an Electronic Data Base for Lung Cancer Registry Which Will Include All the Epidemiological, Clinical, Pathological, Molecular and Treatment Parameters in Lung Cancer Patients Who Are Referred to a Tertiary Oncology Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oncology Center of Biochemical Education And Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Oncology Center of Biochemical Education And Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the light of a new era in the management of lung cancer this non-interventional study&#xD;
      intend to capture all the epidemiological, clinical, pathological, molecular and treatment&#xD;
      parameters of non-small cell (NSCLC) and small cell (SCLC) lung cancer patients from a&#xD;
      tertiary Oncology Clinic in an Electronic Data Base (EDB).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators intend to build an electronic database which will record the epidemiological,&#xD;
      clinical, pathological, molecular data and treatment parameters of lung cancer patients&#xD;
      (NSCLC and SCLC) who are referred to a tertiary Oncology Clinic. Documentation will include:&#xD;
      a) Patient demographics, co- morbidities, tobacco exposure in pack-years, b) Disease related&#xD;
      parameters: method of diagnosis, histological type, disease staging (according to 7th edition&#xD;
      of TNM for lung cancer) and metastatic sites if any, c) Molecular status: mutation status for&#xD;
      Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), Proto-oncogene&#xD;
      tyrosine-protein kinase ROS, Hepatocyte Growth Factor Receptor (HGFRor cMET), Human Epidermal&#xD;
      Growth Factor Receptor 2 (HER2), proto-oncogene B-Raf, and Programmed-Death Ligand 1 (PD-L1)&#xD;
      testing when available, d) Type of treatment (surgery, radiotherapy, chemotherapy, targeted&#xD;
      therapies, immune-therapy), and Line of treatment (neo-adjuvant, adjuvant, 1st, 2nd, 3rd,&#xD;
      palliation therapy), e) Clinical outcome: Overall Survival (OS), Response Rate (RR), and&#xD;
      Progression Free Survival (PFS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2017</start_date>
  <completion_date type="Actual">December 27, 2018</completion_date>
  <primary_completion_date type="Actual">December 27, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>12months</time_frame>
    <description>Overall Survival (OS) will be recorded for all patients and it is defined as the time in months, from diagnosis till death by any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response Rate</measure>
    <time_frame>12 months</time_frame>
    <description>Response Rate (RR) is defined as clinical or objective (imaging) response to treatment. Assessments of objective response will be done according to RECIST 1.1.All relevant data (clinical and radiological assessment) will be recorded and reported chronologically and will be correlated with the line and regimen of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>12 months</time_frame>
    <description>Progression Free Survival (PFS) will be captured for all patients. PFS is defined as the time in months, from the start of the treatment till radiological or clinical progression of the disease or death. PFS will be measured for every line of therapy.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">650</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Lung Cancer patients</arm_group_label>
    <description>All patients with lung cancer that referred to a tertiary Oncology Unit.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with lung cancer that they have been referred to our Unit will be captured to&#xD;
        this electronic database&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Since this will be a non-interventional study all adult patients who will be consent for&#xD;
        registration of their data to EDB will be enrolled.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with insufficient epidemiological or clinical data will be excluded such as&#xD;
             patients with no demographic data or patients that have not taken at least 2 cycles of&#xD;
             therapy.&#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>Konstantinos N Syrigos, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Non-Governmental, Non-Profit Organization</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OCEBER</name>
      <address>
        <city>Athens</city>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>March 13, 2019</last_update_submitted>
  <last_update_submitted_qc>March 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NSCLC</keyword>
  <keyword>SCLC</keyword>
  <keyword>MOLECULAR BIOMARKERS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT03276429
org study id: CA209-9MT
nct id: NCT03276429
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the light of a new era in the management of lung cancer this non-interventional study
      intend to capture all the epidemiological, clinical, pathological, molecular and treatment
      parameters of non-small cell (NSCLC) and small cell (SCLC) lung cancer patients from a
      tertiary Oncology Clinic in an Electronic Data Base (EDB).
Investigators intend to build an electronic database which will record the epidemiological,
      clinical, pathological, molecular data and treatment parameters of lung cancer patients
      (NSCLC and SCLC) who are referred to a tertiary Oncology Clinic. Documentation will include:
      a) Patient demographics, co- morbidities, tobacco exposure in pack-years, b) Disease related
      parameters: method of diagnosis, histological type, disease staging (according to 7th edition
      of TNM for lung cancer) and metastatic sites if any, c) Molecular status: mutation status for
      Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), Proto-oncogene
      tyrosine-protein kinase ROS, Hepatocyte Growth Factor Receptor (HGFRor cMET), Human Epidermal
      Growth Factor Receptor 2 (HER2), proto-oncogene B-Raf, and Programmed-Death Ligand 1 (PD-L1)
      testing when available, d) Type of treatment (surgery, radiotherapy, chemotherapy, targeted
      therapies, immune-therapy), and Line of treatment (neo-adjuvant, adjuvant, 1st, 2nd, 3rd,
      palliation therapy), e) Clinical outcome: Overall Survival (OS), Response Rate (RR), and
      Progression Free Survival (PFS).
observational model: Cohort
time perspective: Retrospective
measure: Overall survival (OS)
time frame: 12months
description: Overall Survival (OS) will be recorded for all patients and it is defined as the time in months, from diagnosis till death by any cause.
measure: Response Rate
time frame: 12 months
description: Response Rate (RR) is defined as clinical or objective (imaging) response to treatment. Assessments of objective response will be done according to RECIST 1.1.All relevant data (clinical and radiological assessment) will be recorded and reported chronologically and will be correlated with the line and regimen of treatment.
measure: Progression Free Survival
time frame: 12 months
description: Progression Free Survival (PFS) will be captured for all patients. PFS is defined as the time in months, from the start of the treatment till radiological or clinical progression of the disease or death. PFS will be measured for every line of therapy.
arm group label: Lung Cancer patients
description: All patients with lung cancer that referred to a tertiary Oncology Unit.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Konstantinos N Syrigos, MD,PhD
role: Principal Investigator
affiliation: Non-Governmental, Non-Profit Organization
facility: 
country: Greece
responsible party type: Sponsor
mesh term: Lung Neoplasms