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Genetic Risk Estimations for Influencing Decision Making in Women at High Risk of Breast Cancer, GENRE 2 Study
Sponsor: Mayo Clinic
Summary
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.
Official title: GENetic Risk Estimation of Breast Cancer Prior to Decisions on Preventive Therapy Uptake, Risk Reducing Surgery or Intensive Imaging Surveillance: A Study to Determine if a Polygenic Risk Score Influences the Decision Making Options Amongst High Risk Women (GENRE 2)
Key Details
Gender
FEMALE
Age Range
35 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
737
Start Date
2019-10-17
Completion Date
2029-12-15
Last Updated
2026-03-05
Healthy Volunteers
Yes
Conditions
Interventions
Polygenic Risk Score
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 %).
Locations (5)
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
Cleveland Clinic
Cleveland, Ohio, United States