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Optimising Mammography Screening Accuracy With Blood-based Biomarkers

Study acronym: OPTIMA
StatusEnrolling by Invitation
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Enrolling by Invitationv3 Show 4 more changesShow less
    • Primary completion date: Nov 20, 2027 to Nov 2028
    • Study completion date: Dec 31, 2028 to Dec 31, 2029
    • Start date changed from estimate of Dec 1, 2025 to Nov 24, 2025
    • Site contacts updated at 2 of 2 sites
  2. Start date: Sep 1, 2025 to Dec 1, 2025v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Vejle Hospital
29 trials monitored
See 2 trials at risk
Breast Cancer
5,418 trials monitored
See 296 trials at risk
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.
Trial Details
NCT Number NCT07049822
Lead Sponsor Vejle Hospital
Collaborators: Sygehus Lillebaelt
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 1,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov