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Inherited Susceptible Genes Among Epithelial Ovarian Cancer

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03015376
Collaborator
(none)
1,000
Enrollment
2
Locations
24
Duration (Months)
500
Patients Per Site
20.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Study Start Date :
    Jan 1, 2017
    Anticipated Primary Completion Date :
    Jan 1, 2019
    Anticipated Study Completion Date :
    Jan 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. herited gene mutations susceptible to epithelial ovarian cancer in patients and their relatives [two years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. epithelial ovarian cancer and their relatves

    2. living in the north of Huaihe River in China

    3. being Han Chinese

    Exclusion Criteria:

    1. non-epithelial ovarian cancer

    2. without specific pathological diagnosis

    3. non-Han Chinese

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lei Li Beijing Beijing China 100730
    2 Peking Union Medical College Hospital Beijing Beijing China 100730

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

    • Principal Investigator: Wu Ming, MD, Peking Union Medical College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lei Li, associate professor, Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT03015376
    Other Study ID Numbers:
    • EOC-GENE
    First Posted:
    Jan 10, 2017
    Last Update Posted:
    Nov 14, 2018
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Lei Li, associate professor, Peking Union Medical College Hospital
    epithelial ovarian cancer
    Hereditary Breast and Ovarian Cancer Syndrome
    next-generation sequencing
    High-Throughput Nucleotide Sequencing
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial
    Hereditary Breast and Ovarian Cancer Syndrome

    Study Results

    No Results Posted as of Nov 14, 2018