Prospective Cohort Study of Germline Variant Carriers With BRCA1 or BRCA2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: BRCA1 and/or BRCA2 Variant Carriers, Ovarian Carcinoma, Fallopian Tube Carcinoma, Peritoneal Carcinoma. Basic parameters: from 20 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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, and peritoneal cancers (loci of BRCA1/2 genetic variants, modifier genes, genetic polymorphism, hormones, and lifestyle habits.) in women carrying BRCA1/2 variants. 3. To estimate the detection rates of occult cancer based on histopathological evaluations, using risk-reducing salpingo-oophorectomy (RRSO). 4. To examine the risk-reducing effect of RRSO on the development of ovarian, fallopian tube, and peritoneal cancers in women carrying BRCA1/2 variants, and compare with those not undergoing RRSO. 5. To identify clinicopathological features in women carrying BRCA1/2 variants who had undergone RRSO. 6. To identify the appropriate interval or degree of surveillance.
Primary outcome measures
- Occurrence of ovarian, fallopian tube, and peritoneal carcinoma [Time frame: up to 15 years]
Secondary outcome measures (6)
- Development of ovarian, fallopian tube, and peritoneal cancers, and the detection rate of occult cancer, based on evaluations of histopathological samples taken post-RSSO. [Time frame: up to 15 years]
- Death from any cause [Time frame: up to 15 years]
- Deaths from ovarian, fallopian tube, and peritoneal cancers. [Time frame: up to 15 years]
- Establishing the detection rate of occult cancer based on histopathological evaluations of samples from RRSO. [Time frame: up to 15 years]
- Development of ovarian, fallopian tube, and peritoneal cancers, including in the post-RRSO period. [Time frame: up to 15 years]
- Death from any cause, including post-RRSO period. [Time frame: up to 15 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Japan · 1 center
- Okayama University — Okayama
Identifiers
NCT: NCT03296826 · JGOG3024 · UMIN000028740