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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


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

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