Personalized Breast Cancer Screening (PRSONAL)
Breast Cancer
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring Risk stratified screening, Risk Assessment, Breast Neoplasms, Early Detection of Cancer, Quality of life, Anxiety, Randomized Controlled Trial, Acceptability
Eligibility Criteria
Inclusion Criteria: Female sex Age between 50 and 67 (both included) years. Invited for the regular breast cancer mammography screening program Signed an informed consent Exclusion Criteria: Personal history of breast cancer Known high risk of breast cancer Ethnic origin, for which the risk model has not been validated.
Sites / Locations
- Dept. of Breast Examinations, Herlev Gentofte Hospital, Copenhagen University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Risk stratified arm
Control arm
The intervention consists of calculation and communication of personal risk together with recommendations for the subsequent interval between screening visits. Women in the intervention arm are offered a risk measurement and risk stratified screening accordingly with stratification into four risk groups: Low, intermediate, elevated and high risk. Depending on the risk group the women will be offered a mammography every 1-4 years. The high risk group will also be offered tomosynthesis. The risk estimation is based on the risk model, BOADICEA, which is the most comprehensive model currently available for breast cancer risk prediction. The model incorporates the most up to date polygenic risk score for breast cancer, based on 313 single nucleotide polymorphisms (SNP), as well as familial breast cancer history, reproductive history, lifestyle/hormonal risk factors, height, weight and mammographic density, obtained from image analysis of the mammogram.
In the control arm, participants are assigned to the standard national screening program with biennial screening.