<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/NCT04452266</url>
  </required_header>
  <id_info>
    <org_study_id>2020_07</org_study_id>
    <secondary_id>2020-A00843-36</secondary_id>
    <nct_id>NCT04452266</nct_id>
  </id_info>
  <brief_title>Predictive Factor Study of the Occurrence of Endometrial Cancer in Patients With Lynch Syndrome</brief_title>
  <acronym>PrediLynch</acronym>
  <official_title>Predictive Factor Study of the Occurrence of Endometrial Cancer in Patients With Lynch Syndrome: Study Conducted in the Hauts-de-France</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</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>
      Lynch Syndrome increases Endometrial Cancer Occurrence in women due to failure in MisMatch&#xD;
      Repair System. Lifetime Cumulative risk of developing endometrial Cancer is approximatively&#xD;
      40% in women with Lynch Syndrome.&#xD;
&#xD;
      Endometrial cancer is the third women cancer in France. Many risk factors are known in&#xD;
      general population. Lots of factors are related to over exposure to estrogen.&#xD;
&#xD;
      Data about influence of general risk factors in Women with Lynch Syndrome are poor. Recently,&#xD;
      a cohort study appears to have shown a significant decrease in the risk of endometrial cancer&#xD;
      with multiparity, the use of hormonal contraception and late menopause in Lynch women. The&#xD;
      impact of weight and certain metabolic parameters on the occurrence of endometrial cancers&#xD;
      remains poorly known to this day.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2020</start_date>
  <completion_date type="Actual">October 20, 2020</completion_date>
  <primary_completion_date type="Actual">October 20, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between endometrial cancer and predictif factors</measure>
    <time_frame>Baseline</time_frame>
    <description>Endometrial cancer (yes/no) and explicative variable: Diabetes before endometrial cancer or Lynch syndrome diagnosis; Smoking ; Maximal Weight ; Age at menarche; Parity ; Age at first birth ; Contraceptive use.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between endometrial cancer and predictif factors in post menopausal woman</measure>
    <time_frame>Baseline</time_frame>
    <description>Endometrial cancer (yes/no) and explicative variable: Menopause age; Hormonal menopause treatment</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Lynch Syndrome</condition>
  <arm_group>
    <arm_group_label>case group</arm_group_label>
    <description>Women with Lynch Syndrome and endometrial Cancer matched on age of endometrial cancer diagnosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>Women with Lynch Syndrome, without Cancer at Lynch Syndrome Diagnostic matched on their age at Lynch Diagnostic</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire assesment</intervention_name>
    <description>Each patient will to answer questions about their medical history.</description>
    <arm_group_label>case group</arm_group_label>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women included are all carriers of Lynch syndrome, already diagnosed by genetic analysis in&#xD;
        the Molecular Biology Laboratory of the CHU de Lille and whose analysis was transmitted&#xD;
        during a consultation at the Guy Fontaine Genetics Clinic during the period from 01/01/1998&#xD;
        to 30/11/2019 at the CHU de Lille or in advanced consultations in the regions.The database&#xD;
        PROGENY will be use to extract population corresponding to the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Lynch Syndrome Diagnosis at University Hospital&#xD;
&#xD;
          -  Alive at study time&#xD;
&#xD;
          -  Age over 30 at endometrial cancer or Lynch Syndrome Diagnosis&#xD;
&#xD;
        Case group :&#xD;
&#xD;
        - No cancer before endometrial cancer diagnosis&#xD;
&#xD;
        Control group :&#xD;
&#xD;
          -  No endometrial cancer developped&#xD;
&#xD;
          -  Free cancer women at Lynch Syndrome diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusing to participate&#xD;
&#xD;
          -  Poor understanding of the French language&#xD;
&#xD;
          -  Other cancer diagnosed before endometrial cancer&#xD;
&#xD;
          -  Hysterectomy before lynch diagnosis for free cancer women&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>woman</gender_description>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Solveig MENU-HESPEL, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Jeanne de Flandres</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>March 8, 2021</last_update_submitted>
  <last_update_submitted_qc>March 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lynch syndrome</keyword>
  <keyword>endometrial cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometrial Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms, Hereditary Nonpolyposis</mesh_term>
    <mesh_term>Syndrome</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/NCT04452266
org study id: 2020_07
secondary id: 2020-A00843-36
nct id: NCT04452266
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Lynch Syndrome increases Endometrial Cancer Occurrence in women due to failure in MisMatch
      Repair System. Lifetime Cumulative risk of developing endometrial Cancer is approximatively
      40% in women with Lynch Syndrome.

      Endometrial cancer is the third women cancer in France. Many risk factors are known in
      general population. Lots of factors are related to over exposure to estrogen.

      Data about influence of general risk factors in Women with Lynch Syndrome are poor. Recently,
      a cohort study appears to have shown a significant decrease in the risk of endometrial cancer
      with multiparity, the use of hormonal contraception and late menopause in Lynch women. The
      impact of weight and certain metabolic parameters on the occurrence of endometrial cancers
      remains poorly known to this day.
observational model: Case-Control
time perspective: Retrospective
measure: Correlation between endometrial cancer and predictif factors
time frame: Baseline
description: Endometrial cancer (yes/no) and explicative variable: Diabetes before endometrial cancer or Lynch syndrome diagnosis; Smoking ; Maximal Weight ; Age at menarche; Parity ; Age at first birth ; Contraceptive use.
measure: Correlation between endometrial cancer and predictif factors in post menopausal woman
time frame: Baseline
description: Endometrial cancer (yes/no) and explicative variable: Menopause age; Hormonal menopause treatment
arm group label: case group
description: Women with Lynch Syndrome and endometrial Cancer matched on age of endometrial cancer diagnosis
arm group label: control group
description: Women with Lynch Syndrome, without Cancer at Lynch Syndrome Diagnostic matched on their age at Lynch Diagnostic
intervention type: Other
intervention name: questionnaire assesment
description: Each patient will to answer questions about their medical history.
arm group label: case group
arm group label: control group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: woman
minimum age: 30 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Solveig MENU-HESPEL, MD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
responsible party type: Sponsor
mesh term: Endometrial Neoplasms
mesh term: Colorectal Neoplasms, Hereditary Nonpolyposis
mesh term: Syndrome
sharing ipd: No