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Recruiting NCT06649123

Triple Assay of Rectal Mucus in the Diagnosis of Colorectal Cancer

Trial Parameters

Condition Colorectal Cancer
Sponsor Origin Sciences
Study Type OBSERVATIONAL
Phase N/A
Enrollment 6,600
Sex ALL
Min Age 18 Years
Max Age 99 Years
Start Date 2024-11-01
Completion 2026-04-01
Interventions
Oricol Test

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.

Eligibility 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.

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