Colorectal Omics and ofCS Proteoglycans (COCO) in Screening and a Diagnostic Pathway
COCO-S
Colorectal OmiCs and Oncofetal Chondroitin Sulfate-modified Proteoglycans in Screening and Colorectal Cancer Diagnostic Pathway
1 other identifier
observational
2,000
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2026
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2025
CompletedFirst Posted
Study publicly available on registry
November 20, 2025
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2031
January 20, 2026
August 1, 2025
2.8 years
November 15, 2025
January 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Colorectal cancer
The value of ofCS proteoglycans in blood plasma as a diagnostic test of finding colorectal cancer at colonoscopy
30 days
Colorectal adenoma
The value of ofCS proteoglycans in blood plasma as a diagnostic test of detecting adenomas at colonoscopy
30 days
Secondary Outcomes (1)
Inflammatory bowel disease
30 days
Study Arms (2)
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.
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.
Interventions
Analyses of ofCS proteoglycans, proteomics (proteins), metabolomics (metabolits) and other biomarkers.
Fecal immunochemical test (FIT), feces sampled by the participant
Eligibility Criteria
People living within the Capital Region of Denmark referred to a screening or colorectal cancer diagnostic pathway colonoscopy
You may qualify if:
- 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
You may not qualify if:
- Patients previously included in the study
- Patients known to be pregnant (pregnancy test not required)
- Non-resident in Denmark.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Copenhagen University Hospital - North Zealand
Hillerød, 3400, Denmark
Copenhagen University Hospital - Amager-Hvidovre
Hvidovre, 2650, Denmark
Biospecimen
Blood including plasma and serum, and stool
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Claus Anders Bertelsen, PhD MD
Copenhagen University Hospital - North Zealand
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2025
First Posted
November 20, 2025
Study Start
March 1, 2026
Primary Completion (Estimated)
November 30, 2028
Study Completion (Estimated)
December 31, 2031
Last Updated
January 20, 2026
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share