BRIP1 Gene Mutation Clinical Trial
Official title:
Cascade Testing in Families With Newly Diagnosed Hereditary Breast and Ovarian Cancer Syndrome
NCT number | NCT04009148 |
Other study ID # | 17-01135 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2019 |
Est. completion date | October 30, 2026 |
Identification of BRCA mutations in ovarian cancer patients may help guide cancer therapies, prognosis, post-operative screening, and other preventative treatments beyond the initial diagnosis. Likewise, genetic testing of ovarian cancer patients for these germline mutations provides invaluable information for families regarding cancer risk, genetic testing, and subsequently indication for risk-reducing surgery. Cascade testing provides a unique opportunity to identify carriers of a deleterious BRCA mutation which can allow for surgical and chemoprevention of prevention of ovarian cancer. There is currently no literature on the rates of referral for the family members.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | October 30, 2026 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - All subjects must have a diagnosis of epithelial ovarian cancer, Fallopian tube caner or primary peritoneal cancer with a known pathogenic genetic mutation. - All subjects must agree to participate. - All subjects must have first or second degree relatives who have not been diagnosed with the same genetic mutation. - A previous diagnosis of cancer in the subject's first or second degree relative is allowed. Exclusion Criteria: - Subjects whose first and/or second degree relatives have already been tested with the subject's known mutations, and no other viable family members are available for testing. |
Country | Name | City | State |
---|---|---|---|
United States | NYU Langone Health | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Establishing the CASCADE Cohort | Number of relatives with successful cascade testing | 1 Year |
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