Study of women with BRCA1 or BRCA2 gene variants and cancer risk
Prospective Cohort Study of Germline Variant Carriers With BRCA1 or BRCA2
This study looks at Japanese women with BRCA1 or BRCA2 gene changes to see how likely they are to develop certain cancers and whether a specific surgery can help prevent them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 20 Years and up |
| Sex | Female |
| Sponsor | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan Academic / other |
| Locations | 1 site (Okayama) |
| Trial ID | NCT03296826 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 20 and older who carry BRCA1 or BRCA2 variants or variants of uncertain significance.
Not a fit: Patients who have already been diagnosed with ovarian, fallopian tube, or peritoneal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into cancer prevention strategies for women with BRCA1/2 variants.
How similar studies have performed: Other studies have shown success in understanding the implications of BRCA1/2 variants, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Okayama
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.