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Spots Global Cancer Trial Database for Clinical Pilot Study for Personalized Risk-based Breast Cancer Screening

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Trial Identification

Brief Title: Clinical Pilot Study for Personalized Risk-based Breast Cancer Screening

Official Title: Clinical Pilot Study for Personalized Risk-based Breast Cancer Screening

Study ID: NCT05731453

Conditions

Breast Cancer

Study Description

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.

Eligibility

Minimum Age: 40 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Vestre Viken Hospital Trust, Drammen, , Norway

Contact Details

Name: Tone Hovda, Phd

Affiliation: Vestre Viken HT

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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