Triple Assay of Rectal Mucus in the Diagnosis of Colorectal Cancer

Development of a Multiomics Assay for Use on OriColTM Sampled Rectal Mucus for Detection of Cancer and Significant Polyps in Symptomatic Patients on the Colorectal Urgent Suspected Cancer Pathway

Development of a multiomics assay for use on OriColTM sampled rectal mucus for detection of cancer and significant polyps in symptomatic patients on the Colorectal Urgent Suspected Cancer pathway.

The primary objectives of the study are:

1. 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.
2. 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.
3. 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:

1. 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:

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

Exclusion Criteria:

1. Patients who are unable to undergo digital rectal examination (DRE).

2. 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

3. Current pregnancy or suspicion of pregnancy.