Development of a Multiomics Assay Using OriColTM Sampled Rectal Mucus to Detect Cancer and Significant Polyps in Symptomatic Patients on the Colorectal Urgent Suspected Cancer Pathway

What this Trial Is About

Researchers are evaluating a new multiomics assay called the Oricol Test, designed to detect colorectal cancer and significant polyps in patients showing symptoms and referred through the urgent suspected cancer pathway. The study aims to confirm known genetic, epigenetic, and microbiome biomarkers linked to colorectal cancer and high-risk adenomas, while also identifying additional rare biomarkers. The research also includes assessing the test's diagnostic performance, including sensitivity and specificity, and evaluating the health economics of delivering this diagnostic service through community centers compared to current pathways. The study involves collecting rectal mucus samples using the Oricol sampling device from patients referred for colonoscopy due to suspected colorectal cancer. This observational study focuses on analyzing these samples to develop and refine biomarker signatures associated with cancer and high-risk polyps. The research will measure various performance metrics of the assay over a 26-month period, alongside an economic assessment of the diagnostic approach. Participants will be adults aged 18 to 99 years who are referred via the urgent suspected cancer colorectal pathway and consent to participate. They will undergo rectal mucus sampling and possibly other clinical examinations like digital rectal exams. The study tracks biomarker presence and diagnostic accuracy while monitoring health economic outcomes. The total observation period for primary and secondary outcomes is 26 months, during which participants' samples and data will be analyzed to evaluate the test's clinical utility and cost-effectiveness.

Triple Assay of Rectal Mucus in the Diagnosis of Colorectal Cancer