NCT06060938

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,200

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
105mo left

Started Feb 2024

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Feb 2024Dec 2034

First Submitted

Initial submission to the registry

September 11, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

February 2, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
7.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2034

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

September 11, 2023

Last Update Submit

March 23, 2026

Conditions

Breast Cancer

Keywords

Risk stratified screeningRisk AssessmentBreast NeoplasmsEarly Detection of CancerQuality of lifeAnxietyRandomized Controlled TrialAcceptability

Outcome Measures

Primary Outcomes (1)

  • Rejection of de-escalated screening intensity in the low risk group

    The fraction of the low risk group, who choose to have the next mammography within two years from the baseline examination and risk calculation, indicating that the women will have rejected the proposed de-escalated screening intensity. The mammography can be of any indication; clinical or screening. Trial success is defined as rejection fraction lower than 30% at 800 days from baseline.

    800 days after enrollment of each participant in the low risk group.

Secondary Outcomes (7)

  • Subject anxiety

    Baseline, day 180, 365, 800

  • Subject breast cancer worry

    Baseline, day 180, 365, 800

  • Subject quality of life

    Baseline, day 180, 365, 800

  • Attrition

    From baseline up to 800 days

  • Regret

    From baseline up to 800 days

  • +2 more secondary outcomes

Study Arms (2)

Risk stratified arm

EXPERIMENTAL

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.

Other: Risk stratified arm

Control arm

ACTIVE COMPARATOR

In the control arm, participants are assigned to the standard national screening program with biennial screening.

Other: Control arm

Interventions

Risk stratified armOTHER

* Complete a questionnaire about family history of breast cancer, lifestyle, reproductive history (baseline) * Measurement of height and weight (baseline) * Complete a mammography (baseline and every 1-4 years according to the risk-group) * Complete questionnaires about quality of life, breast cancer worry and anxiety (safety measures) (baseline, day 180, 365, and 800) * Provide a blood sample for analysis of 313 common genetic variants associated with risk of breast cancer (baseline) * Receive a screening schedule recommendation.

Risk stratified arm
Control armOTHER

* Complete a questionnaire about family history of breast cancer, lifestyle, reproductive history (baseline) * Measurement of height and weight (baseline) * Complete a mammography (baseline and every second year) * Complete questionnaires about quality of life, breast cancer worry and anxiety (safety measures) (baseline, day 180, 365, and 800)

Control arm

Eligibility Criteria

Age50 Years - 67 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female sex
  • Age between 50 and 67 (both included) years.
  • Invited for the regular breast cancer mammography screening program
  • Signed an informed consent

You may not qualify if:

  • Personal history of breast cancer
  • Known high risk of breast cancer
  • Ethnic origin, for which the risk model has not been validated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Breast Examinations, Herlev Gentofte Hospital, Copenhagen University Hospital

Gentofte Municipality, 2900, Denmark

Location

Related Publications (2)

  • Pedersen 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: 41759334RESULT

  • Pedersen 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: 41133331DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsAnxiety Disorders

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesMental Disorders

Study Officials

  • Stig E Bojesen, MD, Professor

    Dept. Clinical Biochemistry, Herlev Gentofte Hospital, Copenhagen University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, DrMedSci, Chief Physician, Clinical Professor

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 29, 2023

Study Start

February 2, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

December 31, 2034

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

DK(1)