<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/NCT04402099</url>
  </required_header>
  <id_info>
    <org_study_id>2019-A00943-54</org_study_id>
    <nct_id>NCT04402099</nct_id>
  </id_info>
  <brief_title>Study KBP-2020-CPHG Documenting New Cases of Primary Lung Cancer (PLC) Diagnosed in Respiratory Medicine Departments and Lung Cancer Units at General Hospitals From January 1st to December 31st 2020</brief_title>
  <acronym>KBP-2020-CPHG</acronym>
  <official_title>Study KBP-2020-CPHG Documenting New Cases of Primary Lung Cancer (PLC) Diagnosed in Respiratory Medicine Departments and Lung Cancer Units at General Hospitals From January 1st to December 31st 2020</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Collège des Pneumologues des Hôpitaux Généraux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Collège des Pneumologues des Hôpitaux Généraux</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Twenty years after KBP-2000-CPHG study and ten years after KBP-2010-CPHG study, the CPHG&#xD;
      proposes to conduct a new epidemiological study on primary PLC in order to evaluate and&#xD;
      analyze the changes that have occurred over the last decade.&#xD;
&#xD;
      Primary endpoint:&#xD;
&#xD;
      Estimate 1-year- and 5-year-mortality rates in patients with PLC.&#xD;
&#xD;
      Secondary endpoints:&#xD;
&#xD;
        -  Describe PLC patient population managed by pulmonologists at French General Hospitals in&#xD;
           2020&#xD;
&#xD;
        -  Describe PLC diagnostic and therapeutic management by pulmonologists at French General&#xD;
           Hospitals in 2020 and compare them to KBP-2000-CPHG and KBP-2010-CPHG studies&#xD;
&#xD;
        -  Estimate prognostic factors&#xD;
&#xD;
        -  Compare patient and tumor characteristics to those observed for KBP-2010-CPHG and&#xD;
           KBP-2000-CPHG studies&#xD;
&#xD;
        -  Compare observed survival rates to those reported for KBP-2000-CPHG and KBP-2010-CPHG&#xD;
           studies&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">January 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2026</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>Estimate 1-year mortality rates in patients with PLC.</measure>
    <time_frame>1 year</time_frame>
    <description>Global survival at 1 year</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimate 5-year mortality rates in patients with PLC.</measure>
    <time_frame>5 years</time_frame>
    <description>Global survival at 5 years</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Describe PLC patient population managed by pulmonologists at French General Hospitals in 2020</measure>
    <time_frame>1 year</time_frame>
    <description>- Patient data: age, gender, birth location, height, weight, comorbidity score, smoking status, cannabis uptake, Performance Status, and death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Describe PLC diagnostic and therapeutic management by pulmonologists at French General Hospitals in 2020 and compare them to KBP-2000-CPHG and KBP-2010-CPHG studies</measure>
    <time_frame>1 year</time_frame>
    <description>- Disease data: diagnostic method, anatomopathological classification, PDL-1 status, molecular biology test, tumor mutation burden, TNM classification, and stage (8th edition)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Lung Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Primary Lung Cancer histologically proven between January 1st and December 31st, 2020&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Primary Lung Cancer histologically (or cytologically or presence of a mutation on&#xD;
             liquid biopsy with compatible imaging) proven between January 1st and December 31st,&#xD;
             2020*&#xD;
&#xD;
          -  Follow-up by a lung specialist at a General Hospital&#xD;
&#xD;
          -  Oral informed consent * date of collected sample&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Secondary lung cancer&#xD;
&#xD;
          -  Recurrence of same histological type PLC- left to the investigator discretion&#xD;
             according to the clinic and the imagery&#xD;
&#xD;
          -  Previous enrolment in the study&#xD;
&#xD;
          -  Freedom deprived patient following a legal or administrative decision&#xD;
&#xD;
          -  Patient unable to give his(her) consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Collège des Pneumologues des Hôpitaux Généraux (CPHG) (General Hospital Pulmonologists College)</name>
      <address>
        <city>Paris</city>
        <zip>75006</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Didier Debieuvre, MD</last_name>
      <phone>+33 (0)3 89 64 73 96</phone>
      <email>debieuvred@ghrmsa.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>April 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04402099
org study id: 2019-A00943-54
nct id: NCT04402099
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Twenty years after KBP-2000-CPHG study and ten years after KBP-2010-CPHG study, the CPHG
      proposes to conduct a new epidemiological study on primary PLC in order to evaluate and
      analyze the changes that have occurred over the last decade.

      Primary endpoint:

      Estimate 1-year- and 5-year-mortality rates in patients with PLC.

      Secondary endpoints:

        -  Describe PLC patient population managed by pulmonologists at French General Hospitals in
           2020

        -  Describe PLC diagnostic and therapeutic management by pulmonologists at French General
           Hospitals in 2020 and compare them to KBP-2000-CPHG and KBP-2010-CPHG studies

        -  Estimate prognostic factors

        -  Compare patient and tumor characteristics to those observed for KBP-2010-CPHG and
           KBP-2000-CPHG studies

        -  Compare observed survival rates to those reported for KBP-2000-CPHG and KBP-2010-CPHG
           studies
observational model: Cohort
time perspective: Prospective
measure: Estimate 1-year mortality rates in patients with PLC.
time frame: 1 year
description: Global survival at 1 year
measure: Estimate 5-year mortality rates in patients with PLC.
time frame: 5 years
description: Global survival at 5 years
measure: Describe PLC patient population managed by pulmonologists at French General Hospitals in 2020
time frame: 1 year
description: - Patient data: age, gender, birth location, height, weight, comorbidity score, smoking status, cannabis uptake, Performance Status, and death
measure: Describe PLC diagnostic and therapeutic management by pulmonologists at French General Hospitals in 2020 and compare them to KBP-2000-CPHG and KBP-2010-CPHG studies
time frame: 1 year
description: - Disease data: diagnostic method, anatomopathological classification, PDL-1 status, molecular biology test, tumor mutation burden, TNM classification, and stage (8th edition)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Lung Neoplasms