<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/NCT03015376</url>
  </required_header>
  <id_info>
    <org_study_id>EOC-GENE</org_study_id>
    <nct_id>NCT03015376</nct_id>
  </id_info>
  <brief_title>Inherited Susceptible Genes Among Epithelial Ovarian Cancer</brief_title>
  <official_title>Cohort Study on Characters and Distribution of Inherited Susceptible Genes Among Epithelial Ovarian Cancer Patients and Their Relatives in the North of China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: To investigate the prevalence of the germline mutations in the BRCA 1/2 and mismatch&#xD;
      repair genes in patients with epithelial ovarian cancer (EOC) and their relatives, and&#xD;
      related somatic mutations in tumor tissues in the northern part of china.&#xD;
&#xD;
      Patients and methods: A multicenter prospective study will be hold in the northern part of&#xD;
      china form 2017. About 1000 female patients with epithelial ovarian cancer and their&#xD;
      ralatives will be tested for germline mutations in the BRCA 1/2 and mismatch repair genes and&#xD;
      related somatic mutations in tumor tissues, regardless of the family history.&#xD;
&#xD;
      Study type: Observational Official title: Prevalence study of germline mutations in&#xD;
      susceptibility ovarian cancer genes in patients with epithelial ovarian cancer and somatic&#xD;
      mutations in their tumor tissures in the northern part of china.&#xD;
&#xD;
      Enrollment: 1000&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">January 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>herited gene mutations susceptible to epithelial ovarian cancer in patients and their relatives</measure>
    <time_frame>two years</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Ovarian Neoplasm Epithelial</condition>
  <condition>Hereditary Breast and Ovarian Cancer Syndrome</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum from peripheral blood and tumor tissues frome surgical samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patiens with epithelia ovarian cancer and their relatves in the North of China&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. epithelial ovarian cancer and their relatves&#xD;
&#xD;
          2. living in the north of Huaihe River in China&#xD;
&#xD;
          3. being Han Chinese&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. non-epithelial ovarian cancer&#xD;
&#xD;
          2. without specific pathological diagnosis&#xD;
&#xD;
          3. non-Han Chinese&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wu Ming, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wu Ming, MD</last_name>
    <phone>+86-13801224549</phone>
    <email>drwuming@sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Li Lei, MD</last_name>
    <phone>+86-13911988831</phone>
    <email>lileigh@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Lei Li</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lei Li, MD</last_name>
      <phone>008613911988831</phone>
      <email>lileigh@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Wu Ming, MD</last_name>
      <phone>+86-13801224549</phone>
      <email>drwuming@sina.com</email>
    </contact>
    <contact_backup>
      <last_name>Li Lei, MD</last_name>
      <phone>+86-13911988831</phone>
      <email>lileigh@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 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>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Lei Li</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <keyword>epithelial ovarian cancer</keyword>
  <keyword>Hereditary Breast and Ovarian Cancer Syndrome</keyword>
  <keyword>next-generation sequencing</keyword>
  <keyword>High-Throughput Nucleotide Sequencing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
    <mesh_term>Hereditary Breast and Ovarian Cancer Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD will be shared with authorised researchers via online database.</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/NCT03015376
org study id: EOC-GENE
nct id: NCT03015376
lead sponsor: 
has dmc: Yes
Purpose: To investigate the prevalence of the germline mutations in the BRCA 1/2 and mismatch
      repair genes in patients with epithelial ovarian cancer (EOC) and their relatives, and
      related somatic mutations in tumor tissues in the northern part of china.

      Patients and methods: A multicenter prospective study will be hold in the northern part of
      china form 2017. About 1000 female patients with epithelial ovarian cancer and their
      ralatives will be tested for germline mutations in the BRCA 1/2 and mismatch repair genes and
      related somatic mutations in tumor tissues, regardless of the family history.

      Study type: Observational Official title: Prevalence study of germline mutations in
      susceptibility ovarian cancer genes in patients with epithelial ovarian cancer and somatic
      mutations in their tumor tissures in the northern part of china.

      Enrollment: 1000
observational model: Cohort
time perspective: Prospective
measure: herited gene mutations susceptible to epithelial ovarian cancer in patients and their relatives
time frame: two years
serum from peripheral blood and tumor tissues frome surgical samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Wu Ming, MD
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
last name: Wu Ming, MD
phone: +86-13801224549
email: drwuming@sina.com
last name: Li Lei, MD
phone: +86-13911988831
email: lileigh@163.com
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Lei Li
investigator title: associate professor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Hereditary Breast and Ovarian Cancer Syndrome
sharing ipd: Yes
ipd description: IPD will be shared with authorised researchers via online database.