<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/NCT04419155</url>
  </required_header>
  <id_info>
    <org_study_id>A00943-54</org_study_id>
    <nct_id>NCT04419155</nct_id>
  </id_info>
  <brief_title>ESCAP-2020-CPHG: Treatment Strategies Follow-up Implemented During the First Three Years Following Primary Lung Cancer (PLC) Diagnosed in KBP-2020-CPHG Cohort Patients</brief_title>
  <acronym>ESCAP-2020</acronym>
  <official_title>ESCAP-2020-CPHG: Treatment Strategies Follow-up Implemented During the First Three Years Following Primary Lung Cancer (PLC) Diagnosed in KBP-2020-CPHG Cohort Patients</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>
      The prognosis for primary lung cancer (PLC) is very limited. In France, patients diagnosed&#xD;
      for PLC in 2010 and followed in Respiratory Medicine or Oncology department of a General&#xD;
      Hospital Centre had a 5-year survival rate of 12.7% (vs 10% in 2000).&#xD;
&#xD;
      Over the last ten years, substantial improvements have been made both in terms of diagnostic&#xD;
      (immunohistochemistry and molecular biology) and therapeutic. New treatments have been&#xD;
      marketed and are now available in clinic.&#xD;
&#xD;
      New therapeutical strategies have been launched and have proved their efficacy in clinical&#xD;
      studies or meta-analyses, generally increasing the survival rate of patients by a few months.&#xD;
      However, little information still exists on the use and effectiveness of these molecules in&#xD;
      clinical practice.&#xD;
&#xD;
      The CPHG proposes to complete the information collected during KPB-2020-CPHG study by the&#xD;
      ESCAP-2020-CPHG study that is a follow-up of therapeutical strategies over the first 3 years&#xD;
      of treatment. This study should improve knowledge of the PLC treatment management in General&#xD;
      Hospital Centres.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Describe therapeutical strategies implemented by pulmonologists in Respiratory Medicine or Oncology department of a General Hospital Centres during the first three years following PLC diagnosed in KBP-2020-CPHG cohort patients.</measure>
    <time_frame>3 years</time_frame>
    <description>Data collected for the ESCAP-2020-CPHG study:&#xD;
- All treatments administered</description>
  </primary_outcome>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Lung Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Primary Lung Cancer histologically or cytologically proven between January 1st and December&#xD;
        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>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 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>
  <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/NCT04419155
org study id: A00943-54
nct id: NCT04419155
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The prognosis for primary lung cancer (PLC) is very limited. In France, patients diagnosed
      for PLC in 2010 and followed in Respiratory Medicine or Oncology department of a General
      Hospital Centre had a 5-year survival rate of 12.7% (vs 10% in 2000).

      Over the last ten years, substantial improvements have been made both in terms of diagnostic
      (immunohistochemistry and molecular biology) and therapeutic. New treatments have been
      marketed and are now available in clinic.

      New therapeutical strategies have been launched and have proved their efficacy in clinical
      studies or meta-analyses, generally increasing the survival rate of patients by a few months.
      However, little information still exists on the use and effectiveness of these molecules in
      clinical practice.

      The CPHG proposes to complete the information collected during KPB-2020-CPHG study by the
      ESCAP-2020-CPHG study that is a follow-up of therapeutical strategies over the first 3 years
      of treatment. This study should improve knowledge of the PLC treatment management in General
      Hospital Centres.
observational model: Cohort
time perspective: Prospective
measure: Describe therapeutical strategies implemented by pulmonologists in Respiratory Medicine or Oncology department of a General Hospital Centres during the first three years following PLC diagnosed in KBP-2020-CPHG cohort patients.
time frame: 3 years
description: Data collected for the ESCAP-2020-CPHG study:
- All treatments administered
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
sharing ipd: No