Triple Assay of Rectal Mucus in the Diagnosis of Colorectal Cancer
Recruiting · NCT06649123 · Observational (researchers observe without assigning treatment) · Lead sponsor: Origin Sciences
View the official record on ClinicalTrials.gov →Interventions studied
Oricol Test
What this trial is about
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
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed.
- Shrewsbury & Telford NHS Foundation Trust - Telford, Shropshire, United Kingdom