NCT04002986
Completed
Not Applicable
Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Women Age 35+ Qualifies if >15% Lifetime Risk of Breast Cancer as Defined by IBIS Version 8
- Sponsor
- Mayo Clinic
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Genetic mutations
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Researchers are trying to learn more about the prevalence of genetic mutations in women who are at intermediate/high risk of breast cancer and how that information my assist providers in improving screening and preventative options.
Investigators
Niloy Jewel (Jewel) Samadder
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Women participating in IRB:18-010601
- •Aged 35 and over with a negative routine mammogram within 3 months.
- •Qualifies as intermediate or high-risk (\>15% lifetime risk of breast cancer as defined by IBIS version 8).
- •Have an active email address for survey completion
Exclusion Criteria
- •Not participating in the Mayo Clinic CEDM pilot (IRB: 18-010601)
- •Known genetic cancer syndrome with test results available for review in Mayo EMR
- •Known breast cancer
- •Unable to understand or sign informed consent
Outcomes
Primary Outcomes
Genetic mutations
Time Frame: One year
Number of subjects to have a pathogenic/likely pathogenic mutations (Positive test result on Proactive Cancer Screening Panel)
Study Participants
Time Frame: One year
Number of subjects who decide to undergo genetic panel testing
Study Sites (1)
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