Brief Title
Prospective Cohort Study of Germline Variant Carriers With BRCA1 or BRCA2
Official Title
Prospective Cohort Study of Germline Variant Carriers With BRCA1 or BRCA2
Brief 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.
Study Type
Observational
Primary Outcome
Occurrence of ovarian, fallopian tube, and peritoneal carcinoma
Secondary Outcome
Development of ovarian, fallopian tube, and peritoneal cancers, and the detection rate of occult cancer, based on evaluations of histopathological samples taken post-RSSO.
Condition
BRCA1 and/or BRCA2 Variant Carriers
Study Arms / Comparison Groups
BRCA1/2 variant carriers
Description: Japanese women who carry BRCA 1/2 variants.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
600
Start Date
November 8, 2017
Completion Date
March 31, 2032
Primary Completion Date
March 31, 2032
Eligibility 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.
Gender
Female
Ages
20 Years - N/A
Contacts
Akira Hirasawa, M.D., Ph.D., +81-86-235-7436, [email protected]
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT03296826
Organization ID
JGOG3024
Secondary IDs
UMIN000028740
Responsible Party
Sponsor
Study Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Okayama University
Study Sponsor
Akira Hirasawa, M.D., Ph.D., Study Chair, Okayama University
Verification Date
December 2022