Status:
COMPLETED
Clinical Impact of Enhanced Risk Assessments in Women With a BRCA1/2 Mutation, CARE Study
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This clinical trial evaluates the impact of enhanced risk assessments on knowledge, perceptions, and decisional conflict about cancer prevention in women with a BRCA1 or BRCA2 mutation. BRCA1/2 mutati...
Detailed Description
PRIMARY OBJECTIVES: I. To deploy tools for delivering enhanced genetic risk predictions based on BRCA1/2 genetic risk modifiers in a clinical setting and assess the impact of risk stratification on g...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Have had genetic counseling and testing for mutations in BRCA1 and/or BRCA2 through a Clinical Laboratory Improvement Act (CLIA)-certified laboratory
- Were found to have a known pathogenic mutation upon testing
- Are within 3 weeks of results disclosure
- Have available medical records for ascertainment of clinical information
- Are able to provide a source of deoxyribonucleic acid (DNA) (blood or mouthwash) for study
- Have access to a telephone and a computer or other internet-ready device
- Have not yet had a bilateral prophylactic mastectomy or bilateral Salpingo oophorectomy
Exclusion
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT06534424
Start Date
January 1 2018
End Date
September 30 2023
Last Update
June 27 2025
Active Locations (2)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
2
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112