NCT07237984 Colorectal Omics and ofCS Proteoglycans (COCO) in Screening and a Diagnostic Pathway
| NCT ID | NCT07237984 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nordsjaellands Hospital |
| Condition | Colorectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2026-08-11 |
| Primary Completion | 2029-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2026-08-11 with a primary completion date of 2029-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Colorectal Cancer (CRC), or bowel cancer, is a serious disease that affects many people globally. The earlier CRC is diagnosed, the better the patient outcomes. The problem with the current diagnostic methods is that they lead to many unnecessary endoscopies (colonoscopies). In Denmark alone, over 30,000 patients every year undergo a colonoscopy without having a serious disease. This puts a major strain on both patients and the healthcare system. This research project aims to solve that problem. COCO-S is investigating oncofoetal chondroitin sulphate-modified proteoglycans (ofCS) to see if ofCS can be used as a novel, unique cancer marker found in the blood. ofCS are special molecules that reappear in most tumour tissues. A method has been developed to detect ofCSs in a simple blood sample. Initial findings from an ongoing study are highly promising. A test using five different ofCS markers has shown very high accuracy in detecting CRC: it correctly identifies 86% of cancer cases (sensitivity) and correctly gives a "negative" result in 97% of cases without cancer (specificity). The results also suggest that high ofCS levels might help clinicians detect adenomas (polyps), which are early precursors to cancer. Combining the analysis of ofCS in the blood with the existing stool test (FIT) and other promising blood markers can significantly improve patient selection for a colonoscopy. This project will collect blood samples from patients scheduled for a colonoscopy. The blood will be analysed for ofCS and other substances to determine the combined predictive value for patients who truly require the procedure. The findings from this project could revolutionize CRC diagnosis. By more accurately identifying patients who need a colonoscopy, the number of unnecessary, invasive procedures can be reduced while maintaining patient safety and ensuring cancer is found in time.
Eligibility 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.
Contact & Investigator
Claus Anders Bertelsen, PhD MD
STUDY CHAIR
Copenhagen University Hospital - North Zealand
Frequently Asked Questions
Who can join the NCT07237984 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07237984 currently recruiting?
Yes, NCT07237984 is actively recruiting participants. Contact the research team at claus.anders.bertelsen@regionh.dk for enrollment information.
Where is the NCT07237984 trial being conducted?
This trial is being conducted at Hillerød, Denmark, Hvidovre, Denmark.
Who is sponsoring the NCT07237984 clinical trial?
NCT07237984 is sponsored by Nordsjaellands Hospital. The principal investigator is Claus Anders Bertelsen, PhD MD at Copenhagen University Hospital - North Zealand. The trial plans to enroll 2,000 participants.
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