NCT03296826

Prospective Cohort Study of Germline Variant Carriers With BRCA1 or BRCA2

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Timeline

• Start date: 2017-11-08
• Primary completion: 2032-03-31
• Completion: 2032-03-31
• First posted: 2017-09-28
• Last updated: 2026-02-03

Locations

1 site across 1 country: Japan