Triple Assay of Rectal Mucus in the Diagnosis of Colorectal Cancer

NCT06649123 | Recruiting DMC

• 1 other identifier: Oricol-EGI-04
• Study Type: observational
• Target: 6,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Adenoma Colon Polyp

Keywords

colon; rectum; mucus; adenoma; microbiome

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Secondary Outcomes (1)

• Health Economic Assessment

  26 months

Interventions

Oricol Test DIAGNOSTIC_TEST

Assessment of diagnostic accuracy of Oricol Sampling device for triage in patients with suspected lower gastrointestinal cancer

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Origin Sciences: lead
• Shrewsbury and Telford Hospitals NHS Trust: collaborator

Study Sites (1)

Shrewsbury & Telford NHS Foundation Trust

Telford, Shropshire, TF33DD, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 36166177 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Sample of rectal mucus containing shed cells from the gastrointestinal tract, microbiome and breakdown products of digestion.

MeSH Terms

Conditions

Colorectal Neoplasms; Adenoma

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Jon Lacy-Colson, FRCS

CONTACT

+44(0)1743261000; jon.lacy-colson@sath.nhs.uk

Ian Daniels, FRCS

CONTACT

+44(0)1256 750490; ian.daniels@originsciences.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 18, 2024
• Study Start: November 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)