Clinical Pilot Study for Personalized Risk-based Breast Cancer Screening

Vestre Viken Hospital Trust

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Genetic: Polygenetic risk score

Study type: Interventional

Funder types: Other

Identifiers

NCT05731453

494936

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 40 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Polygenetic risk score

Experimental group

Description:

Assessment of polygenetic risk score for breast cancer

Treatment:

Genetic: Polygenetic risk score