Clinical Pilot Study for Personalized Risk-based Breast Cancer Screening
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Vestre Viken Hospital Trust
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Assessment of breast cancer risk by polygenetic risk score in the study population
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
The study aims to evaluate the impact of implementing population-based genetics testing strategy for breast cancer precision prevention using the polygenic risk score and monogenic pathogenic variant (MPV) testing in the Norwegian healthcare setting.
Detailed Description
The study will recruit women age 40-50 referred for clinical mammography at the Vestre Viken Breast Center, with mammographic density BI-RADS a or d. After informed consent, saliva from the participants will be sampled and tested for polygenetic risk score (PRS) for breast cancer. The participants will be recommended future mammographic screening based on the PRS (standard screening, or more frequent/start at earlier age). The participants family history of cancer will be assessed, and if indicated, the participants will be referred for full genetic counselling/testing. The study will follow the women for 10 years for development of breast cancer as well as compliance to the recommended follow-up.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women referred for clinical mammography in the Vestre Viken Breast Centre
- •Breast density BI-RADS a or d
- •40-50 y.o.
Exclusion Criteria
- •Prior history of breast cancer or premalignant breast disease
- •Prior genetic counselling/testing
Outcomes
Primary Outcomes
Assessment of breast cancer risk by polygenetic risk score in the study population
Time Frame: 10 years
Polygenetic breast cancer risk score (PRS) as a numeric value with 10 percentile, as absolute 10-year breast cancer risk, and as relative risk compared with average women at the same age
Secondary Outcomes
- Compliance to individual recommedations for breast cancer screening(10 years)
- Correlation of polygenetic risk score and breast cancer risk assessed by family history(10 years)
- Participants´ experience with study participation(10 years)