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NCT Number: NCT03296826

Prospective Cohort Study of Germline Variant Carriers With BRCA1 or BRCA2

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.

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Key information

Conditions

BRCA1 and/or BRCA2 Variant Carriers Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Carcinoma Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Carcinoma Ovarian Diseases Ovarian Neoplasms Peritoneal Carcinoma Urogenital Diseases Urogenital Neoplasms

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Okayama University

Okayama, Japan

Location status: Recruiting

Location contact

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

CONTACT

About this study

  • To estimate the incidence of ovarian, fallopian tube and peritoneal cancers in women carrying BRCA1/2 variants.
  • 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.
  • To estimate the detection rates of occult cancer based on histopathological evaluations, using risk-reducing salpingo-oophorectomy (RRSO).
  • 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.
  • To identify clinicopathological features in women carrying BRCA1/2 variants who had undergone RRSO.
  • To identify the appropriate interval or degree of surveillance.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Occurrence of ovarian, fallopian tube, and peritoneal carcinoma

    Time frame: up to 15 years

    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

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.

    Time frame: up to 15 years

    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.

  2. Death from any cause

    Time frame: up to 15 years

    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.

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

    Time frame: up to 15 years

    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.

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

    Time frame: up to 15 years

    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.

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

    Time frame: up to 15 years

    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.

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

    Time frame: up to 15 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+81-86-235-7436

Sponsors and collaborators

Lead sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Other

Collaborators

  • Japanese Gynecologic Oncology Group
  • Okayama University

Registry information

Important dates

Study start
2017
Primary completion
2032
Study completion
2032
First posted
Sep 28, 2017
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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