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

NCT06714318 | Recruiting

• 1 other identifier: SMARTER
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Correlation between result of blood test and colonoscopy result in patients screened positive for blood in the stool

  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.

  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.

Study Arms (1)

Screening participants

All citizens referred to colonoscopy at Vejle Hospital or Hospital Sønderjylland in the colorectal cancer screening program are offered to participate in the study. If the participant agrees, they will have blood drawn and sign a declaration of consent before their colonoscopy.

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All citizens referred to a colonoscopy at Vejle Hospital or Hospital Sønderjylland in the colorectal cancer screening program.

You may qualify if:

• Participation in the colorectal cancer screening program.

You may not qualify if:

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

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (2)

Hospital Sønderjylland

Aabenraa, 6200, Denmark

RECRUITING

Vejle Hospital

Vejle, 7100, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jonna Skov Madsen, Prof., MD

  Biochemistry and Immunology, Lillebaelt Hospital

  STUDY CHAIR

Central Study Contacts

Line Fly, MD

CONTACT

+4520367215; line.haugaard.fly@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 3, 2024
• Study Start: December 2, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

DK (2)