Status:
RECRUITING
Prospective Cohort Study of Germline Variant Carriers with BRCA1 or BRCA2
Lead Sponsor:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborating Sponsors:
Okayama University
Japanese Gynecologic Oncology Group
Conditions:
BRCA1 And/or BRCA2 Variant Carriers
Ovarian Carcinoma
Eligibility:
FEMALE
20+ years
Brief Summary
To determine the incidence and risk factors in the development of ovarian, fallopian tube, and peritoneal cancers in Japanese women carrying Breast Cancer Susceptibility Gene (BRCA)1/2 variants.
Detailed Description
1. To estimate the incidence of ovarian, fallopian tube and peritoneal cancers in women carrying BRCA1/2 variants. 2. To investigate risk factors concerning the development of ovarian, fallopian tube,...
Eligibility Criteria
Inclusion
- Women carrying BRCA1/2 variants (those with either BRCA1 or BRCA2 variants, or those carrying both variants) and women carrying a variant of uncertain significance (VUS).
- Women who have received sufficient genetic counseling at any medical institution, prior to enrollment to the study.
- Women who provide consent should be 20 years of age or older.
- Women who provide written consent.
Exclusion
- Women without ovarian or fallopian tube cancer at the time of informed consent.
- Women previously diagnosed with ovarian, fallopian tube, or peritoneal cancer, and not excluding those with a personal history of breast cancer development.
- Other individuals considered inappropriate for involvement in this study by the investigator.
Key Trial Info
Start Date :
November 8 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2032
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT03296826
Start Date
November 8 2017
End Date
March 31 2032
Last Update
February 11 2025
Active Locations (1)
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1
Okayama University
Okayama, Japan