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

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Primary completion date: Nov 2026 to May 2027
    • Study completion date: Jan 2028 to Sep 2028
    v4
  2. Site details revised at 1 of 2 sitesv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 28, 2024 to Dec 2, 2024
    • Site details revised at 2 of 2 sites
    • Eligibility criteria expanded, about 1 word
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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.
Trial Details
NCT Number NCT06714318
Lead Sponsor Vejle Hospital
Conditions
(from sponsor)		 Colorectal Cancer
Related terms Colorectal Neoplasms
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov