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RecruitingNCT06714318Updated Jun 29, 2026

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

An observational study in Colorectal Cancer, sponsored by Vejle Hospital. Recruiting at 2 sites in Denmark. Open to participants aged 50 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Vejle Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
50 Years to 74 Years
Sex
All
01

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.

02

Conditions studied

  • Colorectal Cancer
03

Who can participate

Ages eligible
50 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • Participation in the colorectal cancer screening program.

Exclusion criteria

Exclusion Criteria:

  • Participants are excluded if a colonoscopy is not completed unless this is due to a colorectal cancer obstruction.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

05

What researchers measure

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.

    Time frame: 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.

06

Study locations

2 of 2 sites recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06714318
Lead sponsor
Vejle Hospital
Responsible party
Sponsor
First posted
Dec 3, 2024
Start date
Dec 2, 2024
Primary completion
May 2027 (estimated)
Completion
Sep 2028 (estimated)
Last update
Jun 29, 2026

Study contacts

Line Fly, MD
Contact
line.haugaard.fly@rsyd.dk
+4520367215
Jonna Skov Madsen, Prof., MD
study chair · Biochemistry and Immunology, Lillebaelt Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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