<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/NCT03766672</url>
  </required_header>
  <id_info>
    <org_study_id>18_RIPH2_15</org_study_id>
    <secondary_id>2018-A02091-54</secondary_id>
    <nct_id>NCT03766672</nct_id>
  </id_info>
  <brief_title>Characterization of the Genetic Profile of Type 2 Endometrial Carcinoma in Martinique</brief_title>
  <acronym>ENDO-NGS-MQ</acronym>
  <official_title>Characterization of the Genetic Profile of Type 2 Endometrial Carcinoma in Martinique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Center of Martinique</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Martinique Cancer Registry</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Center of Martinique</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 Martinique, about 33 new cases are diagnosed per year, with a high incidence rate of type&#xD;
      2 endometrial carcinoma which has a poor prognosis with few therapeutic options. Although&#xD;
      targeted therapies are used in many types of cancer, they are still possible a minority of&#xD;
      patients. In current practice, endometrial cancers do not benefit these therapies.&#xD;
      Characterization of the molecular mechanisms involved in the genesis of type 2 endometrial&#xD;
      carcinoma could help to identify biomarkers predictive of a response to targeted therapies.&#xD;
      We propose to identify the genetic profile of type 2 endometrial carcinomas in Martinique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Type 2 endometrial carcinomas are often diagnosed at advanced stages, with an high risk of&#xD;
      metastatic recurrence and death even when diagnosed at early stages. They also have few&#xD;
      therapeutic options. The Characterize the mutations responsible of cancer development has led&#xD;
      to develope &quot;precision medicine&quot; that targets &quot;actionable genes&quot; by a drug. This concept of&#xD;
      actionable mutation refers to a change in the DNA molecule that can predict the response to a&#xD;
      drug defined as targeted therapy. Although targeted therapies are used in many types of&#xD;
      cancer, they still target a minority of patients. Some tumor sites still do not benefit from&#xD;
      these treatments. Specifically, type 2 endometrial cancers that have poor prognosis with few&#xD;
      therapeutic options. The characterization of molecular mechanisms, by Next Generation&#xD;
      Sequencing (NGS), involved in the carcinogenesis of endometrial cancers, particularly type 2&#xD;
      cancers, should allow the identification of predictive biomarkers for response to certain&#xD;
      targeted therapies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 22, 2019</start_date>
  <completion_date type="Anticipated">November 22, 2023</completion_date>
  <primary_completion_date type="Actual">November 22, 2021</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>Number of biomarkers identified by Next Generation Sequencing involved in type 2 endometrial tumors in Martinique</measure>
    <time_frame>24 Months</time_frame>
    <description>Characterization of potentially operable mutations in type 2 endometrial tumors from DNA sample withdraw at inclusion and during follow visit</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Endometrial Neoplasms</condition>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <description>Identify the genetic profile of type 2 endometrial carcinomas in Martinique from tumor sample for extraction of tumor DNA .</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Intervention Arm</intervention_name>
    <description>The intervention consists to the characterization of molecular mechanisms using to Next Generation Sequencing (NGS) technique.</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Samples for extraction of DNA on whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Women aged more 18 years living in Martinique with a type 2 endometrial cancer confrimed by&#xD;
        with anatomopathological reports.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major subject living in Martinique with the following characteristics :&#xD;
&#xD;
               -  Patients with type 2 endometrial cancer, with anatomopathological confirmation&#xD;
&#xD;
               -  Affiliate or beneficiary of french social security.&#xD;
&#xD;
               -  Free, informed with a written consent signed by the participant and the&#xD;
                  investigator (at the latest on the day of inclusion and before any research&#xD;
                  required by the research).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 1 adenocarcinoma&#xD;
&#xD;
          -  Patients not affiliated to french social security&#xD;
&#xD;
          -  Refusal to participate.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medhi JEAN-LAURENT, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Martinique</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chu Martinique</name>
      <address>
        <city>Fort-de-France</city>
        <country>Martinique</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Martinique</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>August 3, 2022</last_update_submitted>
  <last_update_submitted_qc>August 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Endometrial carcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Endometrial 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/NCT03766672
org study id: 18_RIPH2_15
secondary id: 2018-A02091-54
nct id: NCT03766672
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In Martinique, about 33 new cases are diagnosed per year, with a high incidence rate of type
      2 endometrial carcinoma which has a poor prognosis with few therapeutic options. Although
      targeted therapies are used in many types of cancer, they are still possible a minority of
      patients. In current practice, endometrial cancers do not benefit these therapies.
      Characterization of the molecular mechanisms involved in the genesis of type 2 endometrial
      carcinoma could help to identify biomarkers predictive of a response to targeted therapies.
      We propose to identify the genetic profile of type 2 endometrial carcinomas in Martinique.
Type 2 endometrial carcinomas are often diagnosed at advanced stages, with an high risk of
      metastatic recurrence and death even when diagnosed at early stages. They also have few
      therapeutic options. The Characterize the mutations responsible of cancer development has led
      to develope "precision medicine" that targets "actionable genes" by a drug. This concept of
      actionable mutation refers to a change in the DNA molecule that can predict the response to a
      drug defined as targeted therapy. Although targeted therapies are used in many types of
      cancer, they still target a minority of patients. Some tumor sites still do not benefit from
      these treatments. Specifically, type 2 endometrial cancers that have poor prognosis with few
      therapeutic options. The characterization of molecular mechanisms, by Next Generation
      Sequencing (NGS), involved in the carcinogenesis of endometrial cancers, particularly type 2
      cancers, should allow the identification of predictive biomarkers for response to certain
      targeted therapies.
observational model: Cohort
time perspective: Prospective
measure: Number of biomarkers identified by Next Generation Sequencing involved in type 2 endometrial tumors in Martinique
time frame: 24 Months
description: Characterization of potentially operable mutations in type 2 endometrial tumors from DNA sample withdraw at inclusion and during follow visit
arm group label: Intervention Arm
description: Identify the genetic profile of type 2 endometrial carcinomas in Martinique from tumor sample for extraction of tumor DNA .
intervention type: Diagnostic Test
intervention name: Intervention Arm
description: The intervention consists to the characterization of molecular mechanisms using to Next Generation Sequencing (NGS) technique.
arm group label: Intervention Arm
Samples for extraction of DNA on whole blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Medhi JEAN-LAURENT, MD
role: Principal Investigator
affiliation: CHU Martinique
facility: 
country: Martinique
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Endometrial Neoplasms
sharing ipd: No