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Trial Title:
Clinical Pilot Study for Personalized Risk-based Breast Cancer Screening
NCT ID:
NCT05731453
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
risk based screening
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Genetic
Intervention name:
Polygenetic risk score
Description:
Polygenetic risk score assessment for breast cancer
Arm group label:
Polygenetic risk score
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.
Criteria for 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
Gender:
Female
Minimum age:
40 Years
Maximum age:
50 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Vestre Viken Hospital Trust
Address:
City:
Drammen
Country:
Norway
Start date:
February 1, 2023
Completion date:
November 11, 2035
Lead sponsor:
Agency:
Vestre Viken Hospital Trust
Agency class:
Other
Collaborator:
Agency:
Oslo University Hospital
Agency class:
Other
Source:
Vestre Viken Hospital Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05731453
