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RecruitingNCT03296826Updated Feb 3, 2026

Prospective Cohort Study of Germline Variant Carriers With BRCA1 or BRCA2

An observational study in BRCA1 and/or BRCA2 Variant Carriers, Ovarian Carcinoma and Fallopian Tube Carcinoma, sponsored by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan. Recruiting at 1 site in Japan. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Ages
20 Years and older
Sex
Female
01

Study 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.

Read the 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.
02

Conditions studied

  • BRCA1 and/or BRCA2 Variant Carriers
  • Ovarian Carcinoma
  • Fallopian Tube Carcinoma
  • Peritoneal Carcinoma
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

BRCA1 and/or BRCA2 variant carriers

Inclusion criteria

  1. 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).
  2. Women who have received sufficient genetic counseling at any medical institution, prior to enrollment to the study.
  3. Women who provide consent should be 20 years of age or older.
  4. Women who provide written consent.

Exclusion criteria

Exclusion Criteria:

  1. Women without ovarian or fallopian tube cancer at the time of informed consent.
  2. Women previously diagnosed with ovarian, fallopian tube, or peritoneal cancer, and not excluding those with a personal history of breast cancer development.
  3. Other individuals considered inappropriate for involvement in this study by the investigator.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • BRCA1/2 variant carriers

    Japanese women who carry BRCA 1/2 variants.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: up to 15 years

Secondary outcomes

  1. 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.

    Time frame: up to 15 years

  2. 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.

    Time frame: up to 15 years

  3. 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.

    Time frame: up to 15 years

  4. 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.

    Time frame: up to 15 years

  5. Development of ovarian, fallopian tube, and peritoneal cancers, including in the post-RRSO period.

    Development of ovarian, fallopian tube, and peritoneal cancers, including in the post-RRSO period is a duration from the date of enrollment to the date of first occurrence of ovarian, fallopian tube, and peritoneal cancer, including in the post-RRSO period.

    Time frame: up to 15 years

  6. Death from any cause, including post-RRSO period.

    Death from any cause, including post-RRSO period is a duration from the date of enrollment to the date of death from any cause, including in the post-RRSO period.

    Time frame: up to 15 years

06

Study locations

1 of 1 sites recruiting
  • Okayama University
    Okayama, Japan
    • Akira Hirasawa, M.D., Ph.D. · Contact
    Recruiting
07

Registry details

Key details

Study ID
NCT03296826
Lead sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Okayama University, Japanese Gynecologic Oncology Group
Responsible party
Sponsor
First posted
Sep 28, 2017
Start date
Nov 8, 2017
Primary completion
Mar 31, 2032 (estimated)
Completion
Mar 31, 2032 (estimated)
Last update
Feb 3, 2026

Study contacts

Akira Hirasawa, M.D., Ph.D.
Contact
hir-aki45@umin.org
+81-86-235-7436
Akira Hirasawa, M.D., Ph.D.
study chair · Okayama University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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