Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot
Not Applicable
Completed
- Conditions
- Women Age 35+ Qualifies if >15% Lifetime Risk of Breast Cancer as Defined by IBIS Version 8
- Interventions
- Genetic: Genetic Testing
- Registration Number
- NCT04002986
- Lead Sponsor
- Mayo Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 116
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Women at intermediate/high risk of breast cancer Genetic Testing Women age 35 years old identified at intermediate/high risk of breast cancer will receive genetic testing
- Primary Outcome Measures
Name Time Method Genetic mutations One year Number of subjects to have a pathogenic/likely pathogenic mutations (Positive test result on Proactive Cancer Screening Panel)
Study Participants One year Number of subjects who decide to undergo genetic panel testing
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States