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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 631
- Locations
- 1
- Primary Endpoint
- Colorectal Cancer
Study Overview
Brief Summary
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.
Detailed Description
Introduction
The demand for early diagnosis of bowel cancer
In the United Kingdom, there are an estimated 41,700 new cases of bowel cancer diagnosed each year and it is the fourth most common cancer. Over 90% of patients that are diagnosed with the earliest stage of bowel cancer will survive at least five years. In 2016 NHS England made £200 million available to ensure we diagnose cancer earlier and faster.
Bowel cancer in symptomatic patients
Patients who present to their GPs that are anaemic or with symptoms of change in bowel habit, rectal bleeding, abdominal pain, bloating or weight loss are often referred to a colorectal clinic under the two-week rule (TWR) scheme. This is designed to enable patients to be seen within two weeks from primary care referral by a specialist clinician to enable quicker diagnosis of a cancer should it be present. Many of these patients will be referred by the colorectal clinician to have a colonoscopy or other form of endoscopy as part of their investigation and work up.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients referred on TWR colorectal cancer pathway to clinic at the Royal Surrey County Hospital
- •Capacity to consent
Exclusion Criteria
- •Has a stoma
- •Previous colorectal cancer
- •Patients lacking capacity to give informed consent
Outcomes
Primary Outcomes
Colorectal Cancer
Time Frame: 28 days
Detection of colorectal cancer via colonoscopy or CT colonography
Secondary Outcomes
- Other Significant Colorectal Disease(28 days)