<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/NCT04456972</url>
  </required_header>
  <id_info>
    <org_study_id>ENDOCIRC</org_study_id>
    <nct_id>NCT04456972</nct_id>
  </id_info>
  <brief_title>Reliability and Interest of Circulating Tumor DNA in Endometrial Cancers.</brief_title>
  <official_title>Pilot Study on the Contribution of Molecular Analysis of Endometrial Cancers: Reliability, and Interest of Circulating Tumor DNA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poitiers University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poitiers University Hospital</source>
  <oversight_info>
    <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 histo-prognostic molecular discoveries of the TCGA (The Cancer Genome Atlas) have&#xD;
      shed new light on the classification of endometrial carcinomas.&#xD;
&#xD;
      After carrying out different types of high-throughput molecular analyzes on 373 endometrial&#xD;
      carcinomas of different histological types, 4 major tumor subtypes could be identified, each&#xD;
      with a different survival profile (the &quot;ultra-mutated&quot; group with POLE mutations, the&#xD;
      &quot;hypermuted&quot; group with microsatellite instability (MSI), the &quot;low number of copies&quot; group,&#xD;
      and the &quot;high number of copies&quot; group).&#xD;
&#xD;
      This histomolecular classification is not yet directly transposable to clinical practice and&#xD;
      tumor genetic characteristics have not had any direct therapeutic impact to date.&#xD;
&#xD;
      The main objective of the study is to determine the concordance rate between molecular&#xD;
      analysis of tumor tissue and that of cDNA in patients with endometrial cancer during&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2020</start_date>
  <completion_date type="Actual">January 8, 2022</completion_date>
  <primary_completion_date type="Actual">January 8, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The main objective of the study is to determine the concordance rate between molecular analysis of tumor tissue and that of cDNA in patients with endometrial cancer during treatment.</measure>
    <time_frame>15 days</time_frame>
    <description>Concordance between molecular analysis of tumor tissue and that of cDNA, in patients with endometrial cancer during treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analysis of the association of molecular anomalies on cDNA with clinical histological data.</measure>
    <time_frame>15 days</time_frame>
    <description>Association of molecular analyzes of tumor tissue DNA with clinical and histological data available at inclusion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of the association of molecular anomalies on cDNA and the amount of total circulating DNA to the radiological response in a metastatic situation.</measure>
    <time_frame>3 months</time_frame>
    <description>Association of the detection of molecular anomalies from cDNA, and the amount of total circulating DNA, with the radiological response in the metastatic population.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Circulating Tumor DNA</condition>
  <condition>Endometrial Cancer</condition>
  <arm_group>
    <arm_group_label>One arm only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>One arm only</intervention_name>
    <description>Samples of plasma to analyze ctDNA</description>
    <arm_group_label>One arm only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven endometrial adenocarcinoma type I or type II.&#xD;
&#xD;
          -  With recent abdomino-pelvic imaging, less than 3 months old.&#xD;
&#xD;
          -  Tumor tissue sufficiently exploitable for research (&gt; 20% of tumor cells)&#xD;
&#xD;
          -  Informed consent signed by the patient after clear and fair information about the&#xD;
             study.&#xD;
&#xD;
          -  Free patient, without tutorship, curatorship or subordination.&#xD;
&#xD;
          -  Patient benefiting from a Social Security scheme or benefiting from it through a third&#xD;
             person.&#xD;
&#xD;
          -  Patient not opposed to participating in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Histologies other than adenocarcinoma (sarcoma, leiomyosarcoma)&#xD;
&#xD;
          -  Linguistic or mental refusal or incapacity to understand and / or sign the informed&#xD;
             consent&#xD;
&#xD;
          -  Patients benefiting from enhanced protection, namely: minors, persons deprived of&#xD;
             their liberty by a judicial or administrative decision, persons staying in a health or&#xD;
             social establishment, adults under legal protection.&#xD;
&#xD;
          -  Pregnant and / or lactating women&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Camille Mrs EVRARD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Poitiers</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Poitiers, PRC</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>January 2, 2023</last_update_submitted>
  <last_update_submitted_qc>January 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2023</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>Endometrial Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Analyzes will be only realised on biology molecular plateform at CHU Poitiers on a first time.&#xD;
If we failed to obtain results we perhaps send plasma in other laboratory</ipd_description>
  </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/NCT04456972
org study id: ENDOCIRC
nct id: NCT04456972
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The recent histo-prognostic molecular discoveries of the TCGA (The Cancer Genome Atlas) have
      shed new light on the classification of endometrial carcinomas.

      After carrying out different types of high-throughput molecular analyzes on 373 endometrial
      carcinomas of different histological types, 4 major tumor subtypes could be identified, each
      with a different survival profile (the "ultra-mutated" group with POLE mutations, the
      "hypermuted" group with microsatellite instability (MSI), the "low number of copies" group,
      and the "high number of copies" group).

      This histomolecular classification is not yet directly transposable to clinical practice and
      tumor genetic characteristics have not had any direct therapeutic impact to date.

      The main objective of the study is to determine the concordance rate between molecular
      analysis of tumor tissue and that of cDNA in patients with endometrial cancer during
      treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The main objective of the study is to determine the concordance rate between molecular analysis of tumor tissue and that of cDNA in patients with endometrial cancer during treatment.
time frame: 15 days
description: Concordance between molecular analysis of tumor tissue and that of cDNA, in patients with endometrial cancer during treatment
measure: Analysis of the association of molecular anomalies on cDNA with clinical histological data.
time frame: 15 days
description: Association of molecular analyzes of tumor tissue DNA with clinical and histological data available at inclusion.
measure: Analysis of the association of molecular anomalies on cDNA and the amount of total circulating DNA to the radiological response in a metastatic situation.
time frame: 3 months
description: Association of the detection of molecular anomalies from cDNA, and the amount of total circulating DNA, with the radiological response in the metastatic population.
arm group label: One arm only
arm group type: Experimental
intervention type: Diagnostic Test
intervention name: One arm only
description: Samples of plasma to analyze ctDNA
arm group label: One arm only
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Camille Mrs EVRARD, PHD
role: Principal Investigator
affiliation: CHU Poitiers
facility: 
country: France
responsible party type: Sponsor
mesh term: Endometrial Neoplasms
sharing ipd: No
ipd description: Analyzes will be only realised on biology molecular plateform at CHU Poitiers on a first time.
If we failed to obtain results we perhaps send plasma in other laboratory