Colorectal CancerNCT06714318
SMARTER: Using Blood Samples to iMprove FIT-bAsed coloRecTal cancEr scReening
An observational study of Colorectal Cancer, run by Vejle Hospital at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Colorectal Cancer
- How many people
- 1,000 participants
- Where
- 2 sitesDenmark
- Study dates
- 2 Dec 2024to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All citizens referred to a colonoscopy at Vejle Hospital or Hospital Sønderjylland in the colorectal cancer screening program.
Who may be able to join
- Participation in the colorectal cancer screening program.
Who cannot join
- Participants are excluded if a colonoscopy is not completed unless this is due to a colorectal cancer obstruction.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Hospital Sønderjylland
Aabenraa, 6200
Line Fly, MD, +45 20367215, line.haugaard.fly@rsyd.dk
- Recruiting
Vejle Hospital
Vejle, 7100
Line Fly, MD, +4520367215, line.haugaard.fly@rsyd.dk
About this study
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
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start2 Dec 2024
- Primary completionMay 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonna Skov Madsen, Prof., MD, Study chair, Biochemistry and Immunology, Lillebaelt Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714318
- Sponsor's protocol ID
- SMARTER
- Status last verified
- Jun 2026
- First submitted
- 27 Nov 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMARTER: Using Blood Samples to iMprove FIT-bAsed coloRecTal cancEr scReening
- ClinicalTrials.gov ID
- NCT06714318
- Acronym / sponsor ID
- SMARTER
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All citizens referred to a colonoscopy at Vejle Hospital or Hospital Sønderjylland in the colorectal cancer screening program.
Key inclusion criteria (1 listed)
- Participation in the colorectal cancer screening program.
Key exclusion criteria (1 listed)
- Participants are excluded if a colonoscopy is not completed unless this is due to a colorectal cancer obstruction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between result of blood test and colonoscopy result in patients screened positive for blood in the stool
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonna Skov Madsen, Prof., MD study chair
Biochemistry and Immunology, Lillebaelt Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Vejle Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Line Fly, MD (+4520367215, line.haugaard.fly@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between result of blood test and colonoscopy result in patients screened positive for blood in the stool (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.