The primary aim of this study is to determine if the addition of an individual polygenic risk score (PRS) in addition to the Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score will aid women at risk of breast cancer in making a decision to take (or not take) medications to prevent breast cancer.
This is a minimal risk prospective multisite study with a single arm incorporating the PRS into a standard breast cancer risk reduction consultation, followed by annual surveys over 10 years to determine if and how the availability of the PRS influenced patient decisions regarding preventive medicine and medication compliance. Because women know beforehand that the PRS is pending, study participants will be advised that a final decision to take preventive medicine must be deferred until after the PRS results are made available. Nevertheless, a survey of understanding of risk and benefit and assessment of willingness to take preventive medicine will be done prior to receiving the PRS results and then another survey will be completed after receiving the PRS score.
Study Type
OBSERVATIONAL
Enrollment
900
A Polygenic Risk Score (PRS) is a blood based genetic test which assesses 300 common breast cancer susceptibility loci (Single Nucleotide Polymorphisms). The PRS has been retrospectively validated and categorizes women into three categories of lifetime risk of developing breast cancer: Low Risk (\<15% lifetime risk), Above Average Risk (15 to 40%), and high risk (\>40 %).
Mayo Clinic
Scottsdale, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
Northwestern University
Evanston, Illinois, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Patient self-reported intention to take a breast cancer preventing medication
Time frame: up to 6 months after initial consultation
Proportion of patients who are taking preventative medications each year for 10 years
Time frame: Each year for up to 10 years
Endocrine related quality of life scores each year for 10 years
Time frame: Each year for up to 10 years
Proportion of patient who are pursuing supplemental screening for 10 years
Time frame: Each year for up to 10 years
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Cleveland Clinic
Cleveland, Ohio, United States