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Clinical Trials in the UK / NCT06649123
Recruiting Observational

Triple Assay of Rectal Mucus in the Diagnosis of Colorectal Cancer

NCT06649123 · tracked via the Priya Life Science UK tracker
Sponsor
Origin Sciences
Phase
Observational
Started
2024-11-01
Last updated
2025-04-04

Condition(s) studied

Colorectal CancerAdenoma Colon Polyp

Investigational drug(s) / intervention(s)

Oricol Test

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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 outcome measure(s)

  • TRIOMIC - 1 — 26 months
    Determination of the clinical utility for stratification of colorectal cancer and high risk adenoma in a symptomatic population using hologenomic analysis.
  • TRIOMIC - 2 — 26 month
    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.
  • TRIOMIC - 3 — 26 months
    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.

Trial sites (1)

FacilityCityRegionStatus
Shrewsbury & Telford NHS Foundation Trust Telford Shropshire Recruiting

More Origin Sciences trials in the UK

Feasibility Study to Investigate Rectal Mucus in Aero-Digestive Tract Cancer. Recruiting

Other trials for the same condition

Feasibility Study to Investigate Rectal Mucus in Aero-Digestive Tract Cancer. Recruiting
First CORRECT Study of Minimal Residual Disease (MRD) Detection in Colorectal Cancer Active, not recruiting
A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A) Recruiting
Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008). Active, not recruiting
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06649123 on ClinicalTrials.gov ↗ ← All trials in the UK