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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06714318

Enrollment

1000

Registered

2024-12-03

Start date

2024-12-02

Completion date

2028-09-01

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 74 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Denmark

Contacts

CONTACTLine Fly, MD

line.haugaard.fly@rsyd.dk+4520367215

STUDY_CHAIRJonna Skov Madsen, Prof., MD

Biochemistry and Immunology, Lillebaelt Hospital

Outcome results