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Prospective Cohort Study of Germline Variant Carriers With BRCA1 or BRCA2

Ovarian Carcinoma Clinical Trial

Official title:
Prospective Cohort Study of Germline Variant Carriers With BRCA1 or BRCA2

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03296826
Study type Observational
Source Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Contact Akira Hirasawa, M.D., Ph.D.
Phone +81-86-235-7436
Email hir-aki45@umin.org
Status Recruiting
Phase
Start date November 8, 2017
Completion date March 31, 2032
View Details
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