Study of women with BRCA1 or BRCA2 gene variants and cancer risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to estimate the incidence of ovarian, fallopian tube, and peritoneal cancers in Japanese women who carry BRCA1 or BRCA2 variants. It will investigate various risk factors associated with cancer development, including genetic variants, lifestyle habits, and hormonal influences. The study will also evaluate the effectiveness of risk-reducing salpingo-oophorectomy (RRSO) in preventing these cancers and assess the detection rates of occult cancers through histopathological evaluations. Additionally, it seeks to identify clinicopathological features and optimal surveillance intervals for these women.

Why it matters

Who can join: the full rules

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:

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.

Where it's running

• Okayama University
  Okayama, Japan Recruiting

Study contacts

• Study coordinator: Akira Hirasawa, M.D., Ph.D.
• Email: hir-aki45@umin.org
• Phone: +81-86-235-7436

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.