Testing rectal mucus for colorectal cancer detection
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
This study is testing a new way to use rectal mucus samples to see if it can help find colorectal cancer and important polyps in patients who need urgent cancer checks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6600 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Origin Sciences Industry-sponsored |
| Locations | 1 site (Telford, Shropshire) |
| Trial ID | NCT06649123 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a multiomics assay using rectal mucus samples to detect colorectal cancer and significant polyps in patients referred for urgent cancer evaluation. It focuses on confirming and refining biomarker signatures related to colorectal cancer and high-risk adenomas, while also assessing the performance metrics of the Oricol™ test. Additionally, the study will evaluate the health economics of this diagnostic service compared to traditional pathways.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 and over who have been referred to the urgent suspected cancer pathway for colorectal issues.
Not a fit: Patients with conditions that prevent a digital rectal examination or those currently pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate detection of colorectal cancer and high-risk adenomas, improving patient outcomes.
How similar studies have performed: While similar approaches have been explored, this specific multiomics assay for rectal mucus is a novel application in the context of colorectal cancer detection.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Telford, Shropshire
- Shrewsbury & Telford NHS Foundation Trust — Telford, Shropshire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Jon Lacy-Colson, FRCS
- Email: jon.lacy-colson@sath.nhs.uk
- Phone: +44(0)1743261000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.