Clinical trial NCT06649123: Triple Assay of Rectal Mucus in the Diagnosis of Colorectal Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Adenoma Colon Polyp
Keywords: colon
rectum
mucus
adenoma
microbiome
Lead sponsor: Origin Sciences
Sponsor class: INDUSTRY
Collaborators: name: Shrewsbury and Telford Hospitals NHS Trust
First posted: 2024-10-18
Enrollment: 6600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 6600 patients referred through the UK Urgent Suspected Cancer Pathway.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: TRIOMIC - 1
timeFrame: 26 months
measure: TRIOMIC - 2
timeFrame: 26 month
measure: TRIOMIC - 3
timeFrame: 26 months
Secondary outcomes:
measure: Health Economic Assessment
timeFrame: 26 months
Other outcomes:
Locations:
city: Telford
country: United Kingdom
facility: Shrewsbury & Telford NHS Foundation Trust
state: Shropshire
Study officials:
References:
citation: Humphrey HN, Diodato A, Isner JC, Walker E, Lacy-Colson J, Nedjai B, Daniels IR; ORI-EGI-02 Study Group. An internal pilot study of a novel rectal mucocellular sampling device to allow next-generation sequencing for colorectal disease. Tech Coloproctol. 2023 Mar;27(3):227-235. doi: 10.1007/s10151-022-02704-y. Epub 2022 Sep 27.