Clinical trial · Observational
Point of Care Faecal Immunochemical Testing for Colorectal Cancer
Can Point of Care Faecal Immunochemical Testing (FIT) be Used in a Clinical Setting for Triage to Endoscopy in the Management of Symptomatic Patients? Prospective Cohort Study to Compare the Results of Point of Care FIT With Endoscopy Findings for Symptomatic Patients Referred to Colorectal Clinic Under the Two-week Rule.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Blood that can be detected in stool via faecal immunochemical testing is a recognised risk factor for the presence of colorectal cancer. There are a number of point of care faecal immunochemical testing devices available. This study is to trial one of these machines into the clinical setting to see if the results are safe and accurate as a 'rule out' test for colorectal cancer. We will be investigating patients that present with symptoms or anaemia to their GP and are referred on the two-week rule pathway to our hospital. It has also been advocated that digital rectal examination (which is part of the routine assessment for a patient presenting to colorectal clinic) provides an opportunity to use a small sample of stool from a gloved finger to perform faecal immunochemical testing. We will be comparing a patient provided sample with a DRE sample on a standard laboratory-based machine.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Faecal Immunochemical Testing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Two-Week Rule Colorectal Patients
- description
- Patients that the GP has referred to two-week rule colorectal clinics at Royal Surrey County Hospital with bowel symptoms or found to be anaemic
- interventionNames
- Diagnostic Test: Faecal Immunochemical Testing
Primary outcomes (1)
- measure
- Colorectal Cancer
- timeFrame
- 28 days
- description
- Detection of colorectal cancer via colonoscopy or CT colonography
Secondary outcomes (1)
- measure
- Other Significant Colorectal Disease
- timeFrame
- 28 days
- description
- Other causes for bowel symptoms (eg colitis or high risk polyps)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients referred on TWR colorectal cancer pathway to clinic at the Royal Surrey County Hospital * Age 18+ * Capacity to consent Exclusion Criteria: * Has a stoma * Previous colorectal cancer * Patients lacking capacity to give informed consent
References
Publications (0)
Data not yet available