Prospective Cohort Study of Germline Variant Carriers with BRCA1 or BRCA2
NCT ID: NCT03296826
Last Updated: 2025-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2017-11-08
2032-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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BRCA1/2 variant carriers
Japanese women who carry BRCA 1/2 variants.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
FEMALE
No
Sponsors
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Okayama University
OTHER
Japanese Gynecologic Oncology Group
OTHER
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
OTHER
Responsible Party
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Principal Investigators
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Akira Hirasawa, M.D., Ph.D.
Role: STUDY_CHAIR
Okayama University
Locations
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Okayama University
Okayama, , Japan
Countries
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Central Contacts
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Facility Contacts
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Akira Hirasawa, M.D., Ph.D.
Role: primary
Other Identifiers
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UMIN000028740
Identifier Type: REGISTRY
Identifier Source: secondary_id
JGOG3024
Identifier Type: -
Identifier Source: org_study_id
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