Clinical Trial

Optimising Mammography Screening Accuracy With Blood-based Biomarkers

Study acronym: OPTIMA
Enrolling by Invitation
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Summary
The project aims to investigate whether breast cancer screening can be improved using blood tests, thereby reducing the number of unnecessary clinical mammographies. The Danish breast cancer screening program was implemented in 2007, and currently, all women aged 50-69 are invited every two years to participate. Those who have a suspecious screening mammography are referred to a clinical mammography where further assesment with more mammographies, ultra-sound and possibly biopsies are conducted. Around 75% of the women that are referred to further assesment can be classified as unnecessary, as no breastcancer is found. This results in avoidable and unpleasant procedures for individuals and strains healthcare resources. The project seeks to reduce the number of these unnecessary clinical mammographies by investigating whether blood biomarkers can identify women at very low risk of breast cancer after a positive mammography screening. By utilizing blood tests, screening could become more personalized, precise, and resource-efficient for the healthcare system.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-06-25; most recent amendment 2026-03-06.
Status change: Not Yet Recruiting → Enrolling by Invitation 2026-03-06
Trial Details
NCT Number NCT07049822
Lead Sponsor Vejle Hospital
Collaborators: Sygehus Lillebaelt
Conditions Breast Cancer
Enrollment 1,200 participants
Start Date 2025-11-24
Primary Completion 2028-11 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-09