Status:
RECRUITING
Triple Assay of Rectal Mucus in the Diagnosis of Colorectal Cancer
Lead Sponsor:
Origin Sciences
Collaborating Sponsors:
Shrewsbury and Telford Hospitals NHS Trust
Conditions:
Colorectal Cancer
Adenoma Colon Polyp
Eligibility:
All Genders
18-99 years
Brief 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.
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 \>1...
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.
Key Trial Info
Start Date :
November 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
6600 Patients enrolled
Trial Details
Trial ID
NCT06649123
Start Date
November 1 2024
End Date
April 1 2027
Last Update
April 4 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shrewsbury & Telford NHS Foundation Trust
Telford, Shropshire, United Kingdom, TF33DD