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Clinical trial

Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot

ID
Name
19-004343
Description
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.
Trial arms
Trial start
2019-08-20
Estimated PCD
2021-05-24
Trial end
2021-05-24
Status
Completed
Treatment
Genetic Testing
A blood draw or saliva kit will be provided to collect subject cells
Arms:
Women at intermediate/high risk of breast cancer
Size
116
Primary endpoint
Genetic mutations
One year
Study Participants
One year
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 116, 'type': 'ACTUAL'}}
Updated at
2023-07-24

1 organization

1 product

1 indication

Organization
Mayo Clinic
Product
Genetic Testing
Indication
Breast Cancer