Triple Assay of Rectal Mucus in the Diagnosis of Colorectal Cancer (TRIOMIC)

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Adenoma Colon Polyp
• Intervention / Treatment: Diagnostic test: Oricol Test

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.

• Study Type: Observational
• Enrollment (Estimated): 6600

Contacts and Locations

• Study Contact: Name: Jon Lacy-Colson, FRCS; Phone Number: +44(0)1743261000; Email: jon.lacy-colson@sath.nhs.uk
• Study Contact Backup: Name: Ian Daniels, FRCS; Phone Number: +44(0)1256 750490; Email: ian.daniels@originsciences.com

Study Locations

• United Kingdom
  • Shropshire
    • Telford, Shropshire, United Kingdom, TF33DD
      • Recruiting
      • Shrewsbury & Telford NHS Foundation Trust
      • Contact: Jon Lacy-Colson, FRCS; Phone Number: +44(0)1952 282993; Email: jon.lacy-colson@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Up to 6600 patients referred through the UK Urgent Suspected Cancer Pathway.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TRIOMIC - 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.	26 month
TRIOMIC - 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.	26 months
TRIOMIC - 1	Determination of the clinical utility for stratification of colorectal cancer and high risk adenoma in a symptomatic population using hologenomic analysis.	26 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Economic Assessment	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.	26 months

Collaborators and Investigators

• Sponsor: Origin Sciences
• Collaborators: Shrewsbury and Telford Hospitals NHS Trust

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: October 16, 2024
• First Submitted That Met QC Criteria: October 17, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: adenoma; microbiome; colon; rectum; mucus
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Pathological Conditions, Anatomical; Intestinal Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplasms, Glandular and Epithelial; Colonic Diseases; Colorectal Neoplasms; Adenoma; Polyps
• Other Study ID Numbers: Oricol-EGI-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: As this study is supporting development of assay for diagnostics, the data will not be shared until completion of the research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No