At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Oricol Test (diagnostic test)
- How long the study runs
- Study runs about 29 months (dates as stated)
- About the drug or intervention
- Oricol Test — diagnostic test: Assessment of diagnostic accuracy of Oricol Sampling device for triage in patients with suspected lower gastrointestinal cancer
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years to 99 Years
- Who
- All
- Number of participants
- 6,600
- Started
- 2024-11-01
- Last checked
- 2025-04
Plain English Summary
What is this study?
- • Testing a new treatment for colorectal cancer
- • Clinical study - 6,600 participants
- • 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
Who can take part?
- • Ages 18 Years to 99 Years
- • Diagnosed with colorectal cancer
Where?
- • Telford - Shrewsbury & Telford NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 99 Years
- Who can join: All genders
What the study is looking for
- ✓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 agreement to take part to participate in the study.
Who cannot take part
- ✗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...
- ✗Patients who have undergone radiotherapy.
- ✗An acute or chronic anal fissure
- ✗Perianal haematoma
See the full criteria
Where Is This Study? (1 UK site)
Shrewsbury & Telford NHS Foundation Trust
Telford TF33DD, United Kingdom
How to Get in Touch
Jon Lacy-Colson, FRCS
Sponsor contactCONTACT
Ian Daniels, FRCS
Sponsor contactCONTACT