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.
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.
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.
BRCA1 and/or BRCA2 variant carriers
Cohort
Prospective
Not listed
Occurrence of ovarian, fallopian tube, and peritoneal carcinoma
Occurrence of ovarian, fallopian tube, and peritoneal carcinoma is a duration from the date of enrollment to the date of first occurrence of ovarian, fallopian tube, and peritoneal carcinoma. If the subjects have undergone RRSO, the duration is defined from the date of enrollment to the date of RRSO conduct
Development of ovarian, fallopian tube, and peritoneal cancers, and the detection rate of occult cancer, based on evaluations of histopathological samples taken post-RSSO.
Development of ovarian, fallopian tube, and peritoneal cancers, and the detection rate of occult cancer is a duration from the date of enrollment to the date of first occurrence of ovarian, fallopian tube, and peritoneal carcinoma. If the subjects have undergone RRSO, the duration is defined from the date of enrollment to the date of RRSO conduct. The occult cancer is defined as ovarian, fallopian tube, peritoneal, and uterine carcinomas (including serious tubal intraepithelial carcinoma, STIC), which is based on evaluations of histopathological samples taken post-RSSO.
Death from any cause
Death from any cause is a duration from the date of enrollment to the date of death from any cause. If the subjects have undergone RRSO, the duration is defined from the date of enrollment to the date of RRSO conduct.
Deaths from ovarian, fallopian tube, and peritoneal cancers.
Deaths from ovarian, fallopian tube, and peritoneal cancers is a duration from the date of enrollment to the date of death from these cancers. If the subjects have undergone RRSO, the term is defined from the date of enrollment to the date of RRSO undergone.
Establishing the detection rate of occult cancer based on histopathological evaluations of samples from RRSO.
The occult cancer is defined as ovarian, fallopian tube, peritoneal, and uterine carcinomas (including serious tubal intraepithelial carcinoma, STIC), which is based on evaluations of histopathological samples taken post-RSSO.
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Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Lead sponsor
Okayama University
Collaborator
Japanese Gynecologic Oncology Group
Collaborator
