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ACTIVE NOT RECRUITING
NCT04474834

Genetic Risk Estimations for Influencing Decision Making in Women at High Risk of Breast Cancer, GENRE 2 Study

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

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

GENETIC

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