Prospective Cohort Study of Germline Variant Carriers With BRCA1 or BRCA2

NCT03296826 | Recruiting DMC

• 2 other identifiers: JGOG3024UMIN000028740
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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

  up to 15 years

Secondary Outcomes (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.

  up to 15 years

• Death from any cause

  up to 15 years

• Deaths from ovarian, fallopian tube, and peritoneal cancers.

  up to 15 years

• Establishing the detection rate of occult cancer based on histopathological evaluations of samples from RRSO.

  up to 15 years

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

  up to 15 years

Study Arms (1)

BRCA1/2 variant carriers

Japanese women who carry BRCA 1/2 variants.

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

BRCA1 and/or BRCA2 variant carriers

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan: lead
• Okayama University: collaborator
• Japanese Gynecologic Oncology Group: collaborator

Study Sites (1)

Okayama University

Okayama, Japan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (all subjects) for Germ-line DNA sequencing, Biospy samples(when subjects have RRSO within follow-up duration)

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Study Officials

• Akira Hirasawa, M.D., Ph.D.

  Okayama University

  STUDY CHAIR

Central Study Contacts

Akira Hirasawa, M.D., Ph.D.

CONTACT

+81-86-235-7436; hir-aki45@umin.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: September 28, 2017
• Study Start: November 8, 2017
• Primary Completion (Estimated): March 31, 2032
• Study Completion (Estimated): March 31, 2032
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

JP (1)