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Recruiting NCT06649123

Triple Assay of Rectal Mucus in the Diagnosis of Colorectal Cancer

— Observational Colorectal Cancer Adenoma Colon Polyp

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oricol Test.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Adenoma Colon Polyp. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

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

Primary outcome measures

  • TRIOMIC - 1 [Time frame: 26 months]
  • TRIOMIC - 2 [Time frame: 26 month]
  • TRIOMIC - 3 [Time frame: 26 months]
Secondary outcome measures (1)
  • Health Economic Assessment [Time frame: 26 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 1 center
  • Shrewsbury & Telford NHS Foundation Trust — Telford

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. PMID 36166177

Identifiers

NCT: NCT06649123 · Oricol-EGI-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗