Colorectal Omics and ofCS Proteoglycans (COCO) in Screening and a Diagnostic Pathway

Sponsor
Nordsjaellands Hospital
Study ID
NCT07237984
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blood sampling — DIAGNOSTIC_TEST
    Analyses of ofCS proteoglycans, proteomics (proteins), metabolomics (metabolits) and other biomarkers.
  • Stool samplong — DIAGNOSTIC_TEST
    Fecal immunochemical test (FIT), feces sampled by the participant

Study Details

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.

Key Dates

First listed
Nov 20, 2025
Start date
Aug 11, 2026
Status verified
Aug 2026
Primary completion
Nov 30, 2029
Completion
Dec 31, 2031

Study Design

Enrollment
2,000 participants (estimated)

Arms

  • Arm: Coloretcal Screening Patients
    In the Danish national colorectal cancer screening programme a full colonoscopy is recommended within 14 days colon after a positive (Faecal Immunochemical Test, FIT) test, defined as \>100 µg Hgb/L (20 µg Hgb/g feces). Patients referred to the study sites will be offered a single blood sample before bowel preparation for the colonoscopy.
  • Arm: Colorectal Cancer Pathway Patients
    In Denmark, patients with symptoms aligning with a suspicion of colorectal cancer are by law to be offered a full colonoscopy within 14 days. Patients referred to the study sites will be offered a single blood sample and a Faecal Immunochemical Test (FIT) before bowel preparation for the colonoscopy.

Primary Outcome Measure

Colorectal cancer [ Time Frame: 30 days ]

Central Contacts

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