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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Colorectal Adenoma; Inflammatory Bowel Disease (IBD)
• Intervention / Treatment: Diagnostic test: Blood sampling; Diagnostic test: Stool samplong

Detailed Description

Colorectal cancer (CRC) is a significant global health burden. Early detection improves outcomes, but current diagnostic pathways lead to many unnecessary colonoscopies. In Denmark, over 30,000 colonoscopies are performed annually on patients without any pathology, burdening both healthcare resources and patients.

This project aims to address this unmet clinical need by investigating the potential of oncofoetal chondroitin sulphate-modified proteoglycans (ofCS) as a novel, tumour-specific biomarker for improved patient allocation to colonoscopy. OfCS are unique molecules that re-emerge in most cancer tissues and can be detected in blood plasma using a proprietary method developed.

Preliminary findings from an ongoing study in CRC patients are highly encouraging. A panel of five ofCS biomarkers has shown high accuracy in detecting CRC, with a cumulative AUC of 0.96, a sensitivity of 86%, and a specificity of 97%. Importantly, these results also suggest that elevated ofCS levels may help detect adenomas, an early precursor to CRC.

Incorporating ofCS analysis into existing diagnostic frameworks, such as the faecal immunochemical test (FIT), will significantly improve the accuracy of patient selection for colonoscopy.

The study assesses whether supplementing the FIT with ofCS analysis and other biomarkers from proteomics and metabolomics can yield a significantly higher AUC of the receiver operating characteristic (ROC) in both the screening and the 'cancer patient pathway'.

This prospective cohort study includes patients undergoing a colonoscopy. Participants blood will be analysed for ofCS, and proteomics and metabolomics biomarkers, to determine their combined predictive value.

The findings from this project could revolutionise CRC diagnosis by creating a tailor-made pathway. By more accurately identifying patients who need a colonoscopy, invasive procedures can be reduced while maintaining patient safety and cancer detection rates.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Claus Anders Bertelsen, PhD MD; Phone Number: +45 51 90 63 03; Email: claus.anders.bertelsen@regionh.dk
• Study Contact Backup: Name: Christina Therkilsen, PhD MSc; Email: christina.therkildsen@regionh.dk

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • Copenhagen University Hospital - North Zealand
    • Contact: Claus Anders Bertelsen, PhD MSc; Phone Number: +45 51 90 63 03; Email: claus.anders.bertelsen@regionh.dk
  • Hvidovre, Denmark, 2650
    • Copenhagen University Hospital - Amager-Hvidovre
    • Contact: Christina Therkildsen, PhD MSc; Email: christina.therkildsen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

People living within the Capital Region of Denmark referred to a screening or colorectal cancer diagnostic pathway colonoscopy

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Blood sampling; Analyses of ofCS proteoglycans, proteomics (proteins), metabolomics (metabolits) and other biomarkers.
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.	Diagnostic test: Blood sampling; Analyses of ofCS proteoglycans, proteomics (proteins), metabolomics (metabolits) and other biomarkers.; Diagnostic test: Stool samplong; Fecal immunochemical test (FIT), feces sampled by the participant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory bowel disease	The value of ofCS proteoglycans in blood plasma as a diagnostic test of finding inflammatory bowel disease at colonoscopy	30 days

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Investigators: Study Chair: Claus Anders Bertelsen, PhD MD, Copenhagen University Hospital - North Zealand

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: November 15, 2025
• First Submitted That Met QC Criteria: November 15, 2025
• First Posted (Estimated): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Biomarker; Colorectal Cancer; Proteomics; Glycoproteins
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Gastroenteritis; Colorectal Neoplasms; Inflammatory Bowel Diseases; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: COCO-S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No