Last updated on February 2020

Prospective Cohort Study of Variant Carriers With BRCA1 or BRCA2


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT03296826

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Keio University

Tokyo, Japan
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