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RecruitingNCT06649123TRIOMICUpdated Apr 4, 2025

Triple Assay of Rectal Mucus in the Diagnosis of Colorectal Cancer

An observational study in Colorectal Cancer and Adenoma Colon Polyp, sponsored by Origin Sciences. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-04-04.

Sponsored by Origin Sciences · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Nov 2024; still recruiting 2 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
6,600
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Colorectal Cancer
  • Adenoma Colon Polyp

Keywords

  • colon
  • rectum
  • mucus
  • adenoma
  • microbiome
03

In context

Colorectal Neoplasms

6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.

This study's planned enrollment of 6,600 is above the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Origin Sciences is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 to participate in the study.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
6,600 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • Diagnostic testOricol Test

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

06

What researchers measure

Primary outcomes

  1. TRIOMIC - 1

    Determination of the clinical utility for stratification of colorectal cancer and high risk adenoma in a symptomatic population using hologenomic analysis.

    Time frame: 26 months

  2. 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.

    Time frame: 26 month

  3. 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.

    Time frame: 26 months

Secondary outcomes

  1. 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.

    Time frame: 26 months

07

Study locations

1 of 1 sites recruiting
  • Shrewsbury & Telford NHS Foundation Trust
    Telford, Shropshire TF33DD, United Kingdom
    Recruiting
08

References and documents

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. PubMed 36166177 ↗

Individual participant data

Plan to share: No — As this study is supporting development of assay for diagnostics, the data will not be shared until completion of the research.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06649123
Lead sponsor
Origin Sciences
Collaborators
Shrewsbury and Telford Hospitals NHS Trust
Responsible party
Sponsor
First posted
Oct 18, 2024
Start date
Nov 1, 2024
Primary completion
Apr 1, 2026 (estimated)
Completion
Apr 1, 2027 (estimated)
Last update
Apr 4, 2025

Study contacts

Jon Lacy-Colson, FRCS
Contact
jon.lacy-colson@sath.nhs.uk
+44(0)1743261000
Ian Daniels, FRCS
Contact
ian.daniels@originsciences.com
+44(0)1256 750490

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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