RecruitingNCT06649123
Triple Assay of Rectal Mucus in the Diagnosis of Colorectal Cancer
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
Sponsor
Origin Sciences
Enrollment
6,600 participants
Start Date
Nov 1, 2024
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 YearsMax Age: 99 Years
Inclusion Criteria3
- 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 Criteria9
- 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.
Interventions
DIAGNOSTIC_TESTOricol Test
Assessment of diagnostic accuracy of Oricol Sampling device for triage in patients with suspected lower gastrointestinal cancer
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06649123
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