NCT05731453

Clinical Pilot Study for Personalized Risk-based Breast Cancer Screening

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Vestre Viken Hospital Trust · Academic / Other
• Sex: Female
• Age: 40 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
GENETIC	Polygenetic risk score	Polygenetic risk score assessment for breast cancer

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-05-01
• Completion: 2035-11-11
• First posted: 2023-02-16
• Last updated: 2024-05-23

Locations

1 site across 1 country: Norway