Colorectal Cancer Screening: a Blood Test for a Better Path to Colonoscopy
Official title: Colorectal OmiCs and Oncofetal Chondroitin Sulfate-modified Proteoglycans in Screening and Colorectal Cancer Diagnostic Pathway
Run by Nordsjaellands Hospital · NCT07237984 · Data updated 2026-11-12
A blood-based biomarker test using five ofCS markers is being tested to better sort people who need a colonoscopy from those who don’t.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | Nordsjaellands Hospital Academic / other |
| Locations | 2 sites (Hillerød and 1 other locations) |
| Status | Recruiting |
| Started | August 11, 2026 |
| Main results expected | November 30, 2029 |
| Study ends | December 31, 2031 |
| Registry record updated | August 24, 2026 |
| Trial ID | NCT07237984 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults in Denmark scheduled for colonoscopy through CRC screening (positive FIT) or cancer pathway, able to consent and speak Danish or English or with interpretation available.
✕Probably not a fit
Patients who have no cancer or adenoma and do not exhibit the biomarker pattern may not benefit from the test.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project explores whether blood markers related to oncofetal chondroitin sulphate (ofCS) can improve decision-making about colonoscopy in people undergoing CRC screening or in the cancer pathway. It combines ofCS analysis with other proteomics and metabolomics markers to see if the test improves accuracy beyond current methods like FIT. The study uses blood and stool samples to develop and validate a biomarker panel, aiming to raise AUC, sensitivity, and specificity for CRC detection and potentially identify adenomas earlier. It is conducted at Danish centers with adults undergoing colonoscopy, and no intervention beyond sample collection is planned. Initial results from related work show promising performance, supporting the potential to reduce unnecessary colonoscopies while maintaining cancer detection.
Why it matters
Potential benefit: If successful, the test could reduce unnecessary colonoscopies by better triaging patients without cancer.
How similar studies have gone: Preliminary studies in CRC patients using a five-marker panel of ofCS show high accuracy (AUC 0.96, sensitivity 86%, specificity 97%).
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients planned to undergo a colonoscopy either as part of the colorectal cancer screening programme due to a positive FIT or within a 'cancer patient pathway' for CRC at one of the study sites. * Able to speak Danish, English, or other languages with sufficient interpretation provided by relatives. * Able to give informed consent Exclusion Criteria: * Patients previously included in the study * Patients known to be pregnant (pregnancy test not required) * Non-resident in Denmark.
Where it's running
-
Copenhagen University Hospital - North Zealand
Hillerød, Denmark Recruiting -
Copenhagen University Hospital - Amager-Hvidovre
Hvidovre, Denmark Recruiting
Study contacts
- Study coordinator: Claus Anders Bertelsen, PhD MD
- Email: claus.anders.bertelsen@regionh.dk
- Phone: +45 51 90 63 03
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.