<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/NCT04493827</url>
  </required_header>
  <id_info>
    <org_study_id>2019PI224</org_study_id>
    <nct_id>NCT04493827</nct_id>
  </id_info>
  <brief_title>Distribution and Prognostic Impact of Oncogenic Drivers in Metastatic Lung Adenocarcinoma : a Retrospective Monocentric Study in Nancy University Hospital Center</brief_title>
  <official_title>Distribution and Prognostic Impact of Oncogenic Drivers in Metastatic Lung Adenocarcinoma : a Retrospective Monocentric Study in Nancy University Hospital Center</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</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>
      The recent discovery of oncogenic drivers has revolutionized the management of advanced lung&#xD;
      cancer by development of tyrosine kinase inhibitors targeted therapies. Prevalence of daily&#xD;
      tobacco use is evaluated at 31,3 % in Grand-Est region, the only French region with a&#xD;
      statistically significative difference for smoking habits. This region shows a higher&#xD;
      incidence (+ 13 %) and mortality for lung cancer in comparison to the average for other&#xD;
      French regions. The objectives of our studie were to estimate the distribution of oncogenic&#xD;
      drivers and analyse their prognostic impacts in the Nancy University Hospital Center&#xD;
      metastatic lung adenocarcinoma's population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2011</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>over a period of 5 years (Day 0 = anatomopathological diagnosis)</time_frame>
    <description>Time (in months) from anatomopathological diagnosis to death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression Free survival</measure>
    <time_frame>over a period of 5 years (Day 0 = anatomopathological diagnosis)</time_frame>
    <description>Time (in months) from anatomopathological diagnosis to progression of the disease assessed by RECIST criteria</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distribution in percentage of main oncogenic drivers in histological samples from metastatic lung adenocarcinoma</measure>
    <time_frame>At base line (Day 0 = anatomopathological diagnosis)</time_frame>
    <description>Distribution in percentage of main oncogenic drivers (KRAS, EGFR, ALK, ROS-1, BRAS and HER2), assessed by Sanger sequencing or FISH method in histological samples from metastatic lung adenocarcinomas</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distribution in percentage of metastasis sites according oncogenic drivers</measure>
    <time_frame>At baseline (Day 0 = anatomopathological diagnosis)</time_frame>
    <description>Distribution in percentage of metastatic sites assessed by CT-scan for metastatic lung adenocarcinomas according oncogenic drivers (KRAS, EGFR, ALK, ROS-1, BRAS and HER2)</description>
  </secondary_outcome>
  <enrollment type="Actual">114</enrollment>
  <condition>Adenocarcinoma of Lung Stage IV</condition>
  <condition>Adenocarcinoma of Lung, Response to Tyrosine Kinase Inhibitor in, Somatic</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with metastatic lung adenocarcinoma diagnosed between 2012 and 2014 with a medical&#xD;
        follow-up entirely done in Nancy Central Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Lung adenocarcinoma&#xD;
&#xD;
          -  Patients diagnosed at a metastatic stage&#xD;
&#xD;
          -  Patient who benefited an oncogenic driver research on their histologic samples&#xD;
&#xD;
          -  Medical follow-up entirely done in Nancy Central Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with double histology&#xD;
&#xD;
          -  Synchronous cancer&#xD;
&#xD;
          -  Patients with surgical care&#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>Angelica Tiotiu</last_name>
    <role>Study Director</role>
    <affiliation>Nancy Central Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Régional Universitaire</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <state>Meurthe Et Moselle</state>
        <zip>54000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 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>Adenocarcinoma</mesh_term>
    <mesh_term>Adenocarcinoma of Lung</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/NCT04493827
org study id: 2019PI224
nct id: NCT04493827
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The recent discovery of oncogenic drivers has revolutionized the management of advanced lung
      cancer by development of tyrosine kinase inhibitors targeted therapies. Prevalence of daily
      tobacco use is evaluated at 31,3 % in Grand-Est region, the only French region with a
      statistically significative difference for smoking habits. This region shows a higher
      incidence (+ 13 %) and mortality for lung cancer in comparison to the average for other
      French regions. The objectives of our studie were to estimate the distribution of oncogenic
      drivers and analyse their prognostic impacts in the Nancy University Hospital Center
      metastatic lung adenocarcinoma's population.
observational model: Cohort
time perspective: Retrospective
measure: Overall survival
time frame: over a period of 5 years (Day 0 = anatomopathological diagnosis)
description: Time (in months) from anatomopathological diagnosis to death
measure: Progression Free survival
time frame: over a period of 5 years (Day 0 = anatomopathological diagnosis)
description: Time (in months) from anatomopathological diagnosis to progression of the disease assessed by RECIST criteria
measure: Distribution in percentage of main oncogenic drivers in histological samples from metastatic lung adenocarcinoma
time frame: At base line (Day 0 = anatomopathological diagnosis)
description: Distribution in percentage of main oncogenic drivers (KRAS, EGFR, ALK, ROS-1, BRAS and HER2), assessed by Sanger sequencing or FISH method in histological samples from metastatic lung adenocarcinomas
measure: Distribution in percentage of metastasis sites according oncogenic drivers
time frame: At baseline (Day 0 = anatomopathological diagnosis)
description: Distribution in percentage of metastatic sites assessed by CT-scan for metastatic lung adenocarcinomas according oncogenic drivers (KRAS, EGFR, ALK, ROS-1, BRAS and HER2)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Angelica Tiotiu
role: Study Director
affiliation: Nancy Central Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Adenocarcinoma of Lung