<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/NCT03291106</url>
  </required_header>
  <id_info>
    <org_study_id>EC-LYNCH</org_study_id>
    <nct_id>NCT03291106</nct_id>
  </id_info>
  <brief_title>Study of Universal Screening for Lynch Syndrome in Chinese Patients of Endometrial Cancer</brief_title>
  <official_title>Cohort Study of Universal Screening for Lynch Syndrome in Chinese Patients of Endometrial Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lei Li</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</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 patients diagnosed as endometrial cancer by thorough pathologic examinations, Lynch&#xD;
      syndromes are screened by (1)immunohistochemical staining (for MLH1, MSH2, MSH6 and PMS2),&#xD;
      (2) tests of microsatellite instability and (3) clinical criteria (Amsterdam I or II criteria&#xD;
      and Bethesda criteria). For patients with any suspicious discoveries of Lynch syndromes from&#xD;
      aforementioned screening methods, a molecular diagnosis with next-generation sequencing for&#xD;
      mismatch repair genes (MLH1, MSH2, MSH6, PMS2, and EPCAM) is given to confirm Lynch&#xD;
      syndromes. For patients of Lynch syndromes and endometrial cancer, relatives of blood lineage&#xD;
      are tested by Sanger method or qPCR to find out carriers of mutation genes of Lynch&#xD;
      syndromes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">October 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 1, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Distribution of Lynch syndromes in endometrial cancer</measure>
    <time_frame>2 years</time_frame>
    <description>Proportions of patients carrying mismatch repair gene in endometrial cancer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reliability of immunohistochemical staining for screening Lynch syndromes</measure>
    <time_frame>2 years</time_frame>
    <description>Sensitiviy and specitiviy of immunohistochemical staining for screening Lynch syndromes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reliability of microsatellite instability for screening Lynch syndromes</measure>
    <time_frame>2 years</time_frame>
    <description>Sensitiviy and specitiviy of microsatellite instability for screening Lynch syndromes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reliability of clinical criteria for screening Lynch syndromes</measure>
    <time_frame>2 years</time_frame>
    <description>Sensitiviy and specitiviy of clinical criteria for screening Lynch syndromes</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Colorectal Neoplasms, Hereditary Nonpolyposis</condition>
  <condition>Endometrial Neoplasms</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>immunohistochemical staining</intervention_name>
    <description>immunohistochemical staining for MLH1, MSH2, MSH6 and PMS2</description>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>tests of microsatellite instability</intervention_name>
    <description>microsatellite instability in tissues of endometrial cancer</description>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>clinical criteria of Lynch syndromes</intervention_name>
    <description>Amsterdam I or II criteria and Bethesda criteria</description>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>sequencing for mismatch repair genes</intervention_name>
    <description>next-generation sequencing, Sanger method or qPCR for mismatch repair genes (MLH1, MSH2, MSH6, PMS2, and EPCAM)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patiens with definite diagnosis of endometrial cancer, including type I and type II&#xD;
        endometrial cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Survivals of endometrial cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Metatatic malignacies to uterine&#xD;
&#xD;
          -  Leiomyosarcoma of uterus&#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>Lei Li, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lei Li, MD</last_name>
    <phone>13911988831</phone>
    <phone_ext>+86</phone_ext>
    <email>lileigh@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Lei Li</name>
      <address>
        <city>Beijing</city>
        <state>China/Beiing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lei L Li, MD</last_name>
      <phone>13911988831</phone>
      <phone_ext>+86</phone_ext>
      <email>lileigh@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>November 9, 2018</last_update_submitted>
  <last_update_submitted_qc>November 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Lei Li</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Endometrial Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms, Hereditary Nonpolyposis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Distributions of specific mutation genes of Lynch syndromes will be available for other researches by officially published papers.</ipd_description>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </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/NCT03291106
org study id: EC-LYNCH
nct id: NCT03291106
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In patients diagnosed as endometrial cancer by thorough pathologic examinations, Lynch
      syndromes are screened by (1)immunohistochemical staining (for MLH1, MSH2, MSH6 and PMS2),
      (2) tests of microsatellite instability and (3) clinical criteria (Amsterdam I or II criteria
      and Bethesda criteria). For patients with any suspicious discoveries of Lynch syndromes from
      aforementioned screening methods, a molecular diagnosis with next-generation sequencing for
      mismatch repair genes (MLH1, MSH2, MSH6, PMS2, and EPCAM) is given to confirm Lynch
      syndromes. For patients of Lynch syndromes and endometrial cancer, relatives of blood lineage
      are tested by Sanger method or qPCR to find out carriers of mutation genes of Lynch
      syndromes.
observational model: Cohort
time perspective: Prospective
measure: Distribution of Lynch syndromes in endometrial cancer
time frame: 2 years
description: Proportions of patients carrying mismatch repair gene in endometrial cancer
measure: Reliability of immunohistochemical staining for screening Lynch syndromes
time frame: 2 years
description: Sensitiviy and specitiviy of immunohistochemical staining for screening Lynch syndromes
measure: Reliability of microsatellite instability for screening Lynch syndromes
time frame: 2 years
description: Sensitiviy and specitiviy of microsatellite instability for screening Lynch syndromes
measure: Reliability of clinical criteria for screening Lynch syndromes
time frame: 2 years
description: Sensitiviy and specitiviy of clinical criteria for screening Lynch syndromes
intervention type: Diagnostic Test
intervention name: immunohistochemical staining
description: immunohistochemical staining for MLH1, MSH2, MSH6 and PMS2
intervention type: Diagnostic Test
intervention name: tests of microsatellite instability
description: microsatellite instability in tissues of endometrial cancer
intervention type: Diagnostic Test
intervention name: clinical criteria of Lynch syndromes
description: Amsterdam I or II criteria and Bethesda criteria
intervention type: Diagnostic Test
intervention name: sequencing for mismatch repair genes
description: next-generation sequencing, Sanger method or qPCR for mismatch repair genes (MLH1, MSH2, MSH6, PMS2, and EPCAM)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lei Li, MD
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
last name: Lei Li, MD
phone: 13911988831
phone ext: +86
email: lileigh@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Lei Li
investigator title: Professor
mesh term: Neoplasms
mesh term: Endometrial Neoplasms
mesh term: Colorectal Neoplasms
mesh term: Colorectal Neoplasms, Hereditary Nonpolyposis
sharing ipd: Yes
ipd description: Distributions of specific mutation genes of Lynch syndromes will be available for other researches by officially published papers.
ipd info type: Clinical Study Report (CSR)