About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients previously included in the study
Patients known to be pregnant (pregnancy test not required)
Non-resident in Denmark.
Trial population
People living within the Capital Region of Denmark referred to a screening or colorectal cancer diagnostic pathway colonoscopy
Trial design
Cohort
Prospective
Treatments tested in this trial
Blood sampling
Diagnostic testAnalyses of ofCS proteoglycans, proteomics (proteins), metabolomics (metabolits) and other biomarkers.
Stool samplong
Diagnostic testFecal immunochemical test (FIT), feces sampled by the participant
Treatment groups
Trial outcomes
Primary outcomes
Colorectal cancer
The value of ofCS proteoglycans in blood plasma as a diagnostic test of finding colorectal cancer at colonoscopy
Colorectal adenoma
The value of ofCS proteoglycans in blood plasma as a diagnostic test of detecting adenomas at colonoscopy
Secondary outcomes
Inflammatory bowel disease
The value of ofCS proteoglycans in blood plasma as a diagnostic test of finding inflammatory bowel disease at colonoscopy
Sponsors and contacts
Click on the lead sponsor to view all of their trials.