Colorectal Omics and ofCS Proteoglycans (COCO) in Screening and a Diagnostic Pathway
Recruiting · NCT07237984 · Observational (researchers observe without assigning treatment) · Lead sponsor: Nordsjaellands Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
2 locations listed.
- Copenhagen University Hospital - North Zealand - Hillerød, Denmark
- Copenhagen University Hospital - Amager-Hvidovre - Hvidovre, Denmark