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

NCT06714318 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-06-18

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Vejle Hospital

    lead OTHER

Principal Investigators

  • Jonna Skov Madsen, Prof., MD · Biochemistry and Immunology, Lillebaelt Hospital

Eligibility

Min Age
50 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-02
Primary Completion
2026-11-30
Completion
2028-01-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06714318 on ClinicalTrials.gov