Capturing BRCA1/2 Mutational Status in Women With High Grade Serous Ovarian Cancer and Impact on Clinical Outcome.
NCT ID: NCT02341118
Last Updated: 2023-07-27
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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TERMINATED
109 participants
OBSERVATIONAL
2014-05-31
2023-05-08
Brief Summary
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This study will be an opportunity for patient to improve access at genetic and molecular testing for BRCA1/2 mutation which could impact her future treatment option. Moreover, this study will allow to prospectively assess the proportion of patients with BRCA mutation in ovarian cancer and describe the type of mutations identified in a large population.
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Detailed Description
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· To provide genomic profiling for BRCA1 and BRCA2 mutational status in patients' with high grade serous ovarian cancer.
Secondary Objectives
* To track the number of women with high grade serous ovarian cancer who are being screened in Princess Margaret Cancer Center for mutations in BRCA1/2
* To track accrual rates and clinical outcomes in patients with high grade serous ovarian cancer who are BRCA1/2-positive
* To correlate impact of BRCA1/2 mutational status on clinical outcome
* To track utilization of genetic counseling services at Princess Margaret Cancer Centre
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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BRCA genetic data
Two blood samples will be taken which is part of the standard of care. Tumor samples will be obtained from previous biopsy or surgery prior to this study for DNA testing
Eligibility Criteria
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Inclusion Criteria
* Patient must be ≥18 years old
* All patients must have sufficient archival tumor tissue for molecular analysis
* All patients must consent to have a genetic testing
* All patients must have signed and dated an informed consent form
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Amit Oza
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
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Other Identifiers
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BRCA Screening
Identifier Type: -
Identifier Source: org_study_id
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