Triple Assay of Rectal Mucus in the Diagnosis of Colorectal Cancer

The primary objectives of the study are:

• Confirm the presence of established genetic, epigenetic and microbiome based biomarker signatures associated with CRC and high-risk adenoma (defined as >10mm in diameter or the presence of high-grade dysplasia) in colorectal urgent suspected cancer referrals, who are triaged for colonoscopy.
• To expand and refine the genomic, epigenetic and microbiome biomarker signature profiles associated with colorectal cancer and high-risk adenoma to identify rarer biomarkers in addition to those previously established.
• To generate indicative performance metrics, including an assessment of discriminatory power, sensitivity, specificity and negative predictive values for the clinical application of Oricol™ multiomics assay.

The Secondary Objectives of the study are:

• To assess the health economics of delivering a diagnostic service to patients referred to the urgent suspected cancer (USC) pathway via a Community Diagnostic Centre (CDC) in comparison to the current delivery mechanisms through the Two-Week Wait (TWW) pathway.

Inclusion criteria

• Patients 18 years and over
• Patients referred from primary care to the 'urgent suspected cancer' CRC pathway during the study period.
• Patients who provide voluntary written informed consent to participate in the study.

Exclusion criteria

• Patients who are unable to undergo digital rectal examination (DRE).
• Patients with peri-anal/anal symptoms that may limit DRE and proctoscopy examination and it would be clinically inappropriate to attempt to assess these patients. This may include conditions such as:

• Patients who have undergone radiotherapy.
• An acute or chronic anal fissure
• Perianal haematoma
• Acute thrombosed haemorrhoids
• Post- operative anal stenosis
• The presence of an obstructing anal/low rectal tumour or discomfort as a result of previous pelvic radiotherapy
• Current pregnancy or suspicion of pregnancy.