Women Age 35+ Qualifies if >15% Lifetime Risk of Breast Cancer as Defined by IBIS Version 8
Conditions
Keywords
increased risk of breast cancer
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.
Interventions
GENETICGenetic Testing
A blood draw or saliva kit will be provided to collect subject cells
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed