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

Recruiting

• Conditions: Colorectal Cancer

• Registration Number: NCT06714318
• Lead Sponsor: Vejle Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-11-27
• Status Verified: 2024-12
• Study Start: 2024-12-02
• Study First Posted: 2024-12-03
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-27
• Primary Completion: 2026-11
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Participation in the colorectal cancer screening program.

Exclusion Criteria

• Participants are excluded if a colonoscopy is not completed unless this is due to a colorectal cancer obstruction.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between result of blood test and colonoscopy result in patients screened positive for blood in the stool	From enrollment in study till 120 days after colonoscopy. The blood sample will be drawn before the colonoscopy and the final diagnosis from the colonoscopy will be registered 120 days after the colonoscopy.	The aim is to investigate the individual's chance of being healthy despite a positive test for blood in the stool in the colorectal cancer screening program. The chance of being healthy is estimated from the combined blood sample results and will be compared to the results of the colonoscopy.

Trial Locations

Locations (2)

Hospital Sønderjylland; 🇩🇰 Aabenraa, Denmark

Vejle Hospital; 🇩🇰 Vejle, Denmark