Clinical trial · Interventional
Personalized Breast Cancer Screening
Population-based Randomized Study Of a Novel Breast Cancer Risk ALgorithm and Stratified Screening
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to measure short-term safety and efficacy of personalized vs. standard mammography screening among 50-67-year aged women. The CE-marked risk model incorporates genetic data, family history, lifestyle/hormonal factors and mammographic density. Consenting women will be 1:1 randomized to a control group receiving no risk measurement and continuing their normal biennial mammography, while women in the intervention group will receive risk measurement and an ensuing risk stratified screening programme. Questionnaire information on life quality, breast cancer worry and anxiety will be collected at baseline and different timepoints later from both groups. The primary endpoint - the fraction of low risk women rejecting the recommended extension of screening interval from 2 to 4 years, will be measured 2 years and 4 years after inclusion. PRSONAL will be a success if this fraction is lower than 30%. Secondary outcomes, include quality of life, breast cancer worry and anxiety. Commitment from the target group is key for success, and interview studies followed by a questionnaire survey among women will feed into construction of a citizen directed web-based Risk Communication Tool. This tool will collect risk information, present the risk estimate and provide individual risk communication, while monitoring involvement, acceptance, and psychosocial consequences of personalized screening. The large volume of individuals undergoing screening, necessitates automated, but individualized interaction with the screened individuals. The tool will constitute such a platform. In total, 2200 women will be randomized 1:1 without blinding to a control group assigned to the standard screening program, and an intervention group, which will be offered a risk measurement and risk stratified screening accordingly. Women in the intervention group are stratified into four risk groups. Depending on the risk group the women will be offered a mammography every 1-4 years. The control group are assigned to the standard national screening program with biennial screening. The primary outcome of the study will be the proportion of women in the low risk group, who choose to have the next mammography within two years from the enrollment, indicating that the women will have rejected the proposed de-escalated screening intensity. Moreover, potential harms such as increased anxiety, worry or reduced quality of life will be measured via self-report questionnaires.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control arm | Other | — | UNRESOLVED |
| Risk stratified arm | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Risk stratified arm
- description
- 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.
- interventionNames
- Other: Risk stratified arm
- type
- ACTIVE_COMPARATOR
- label
- Control arm
- description
- In the control arm, participants are assigned to the standard national screening program with biennial screening.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 67 Years
Show eligibility criteria text
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.
References
Publications (2)
- RESULTPedersen LH, Bigaard J, Vejborg I, Kamstrup PR, Andersen B, Yang X, Ficorella L, Dennis J, Antoniou AC, Flyger H, Bojesen SE. Risk Stratified Breast Cancer Screening: Early Outcomes and Psychological Impact from PRSONAL - a Randomized Clinical Trial. Breast. 2026 Apr;86:104743. doi: 10.1016/j.breast.2026.104743. Epub 2026 Feb 24. PMID 41759334
- DERIVEDPedersen LH, Bigaard J, Kamstrup PR, Andersen B, Vejborg I, Antoniou AC, Bojesen SE. Risk-stratified breast cancer screening - a protocol for a non-blinded randomised trial. Dan Med J. 2025 Oct 15;72(11):A03250154. doi: 10.61409/A03250154. PMID 41133331