Clinical Trial

SMARTER: Using Blood Samples to iMprove FIT-bAsed coloRecTal cancEr scReening

Recruiting
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Summary
The project aims to investigate whether colorectal cancer screening can be improved using blood tests, thereby reducing the number of unnecessary colonoscopies. The Danish colorectal cancer screening program was implemented in 2014, and currently, all individuals aged 50-74 are invited every two years to participate. Those who test positive for hidden blood in their stool are referred for a colonoscopy. More than a third of the approximately 25,000 colonoscopies performed annually in the screening program can be classified as unnecessary, as they reveal a normal colon. This results in avoidable and unpleasant procedures for individuals and strains healthcare resources. The project seeks to reduce the number of these unnecessary colonoscopies by investigating whether blood biomarkers can identify individuals at very low risk of colorectal cancer after a positive stool test for hidden blood. By utilizing blood tests, screening could become more personalized, precise, and resource-efficient for the healthcare system.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-11-27; most recent amendment 2026-06-26.
Status change: Not Yet Recruiting → Recruiting 2024-12-19
Trial Details
NCT Number NCT06714318
Lead Sponsor Vejle Hospital
Conditions Colorectal Cancer
Enrollment 1,000 participants
Start Date 2024-12-02
Primary Completion 2027-05 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-06-29