Colorectal Cancer Clinical Trial
— RECEDEOfficial title:
Reducing Colonoscopies in Patients Without Significant Bowel Disease
Investigating people with bowel symptoms uses a test that detects traces of blood in the stools, the FIT test. There are many possible reasons for positive tests. A few people have cancer. However, most participants with symptoms don't have any serious bowel disease but have benign problems such as piles or irritable bowel syndrome (IBS). It is very difficult to diagnose on symptoms alone, those participants who have serious bowel disease and those who do not. After a positive test, people are invited for colonoscopy - a sort of articulated tube that is passed up the bowel. Most people invited for colonoscopy don't have cancer. Only about 5% of those with positive FIT tests have cancer. About 25% have other bowel diseases, but most have nothing serious wrong at all. So they have the inconvenience and discomfort of colonoscopy but don't get any benefit from it. The investigators want to try adding another test, the volatile organic compound (VOC) test, to see if the investigators can separate those with positive FIT tests who do have something wrong, from those who don't. The VOC test uses a urine sample. Using both tests might also be better for detecting cancer. FIT alone misses about 20%. So the investigators think that using both tests might not only be better for detecting cancer, but also might mean that a lot of people will avoid having to have colonoscopy. This study will recruit 1,819 participants with bowel symptoms from NHS trusts in the UK. They will provide stool samples for FIT and urine for VOC analysis. They will have colonoscopy to get a definite diagnosis. Then the investigators will look at their FIT and VOC test results to see if in future, people with both tests negative.
Status | Recruiting |
Enrollment | 1819 |
Est. completion date | October 31, 2023 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - - All participants referred either routinely with lower gastrointestinal symptoms or urgently (fulfilling the national criteria for referral - NICE NG12) for colonoscopy investigation that is determined by their overseeing clinician - Minimum age of 18 - Able to provide informed consent - Have the ability to return both stool and urine samples Exclusion Criteria: - Those who are pregnant |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospital Coventry and Warwickshire NHS Trust | Coventry | West Midlands |
United Kingdom | University Hospital Derby & Burton | Derby | |
United Kingdom | East Cheshire NHS Trust | Macclesfield | |
United Kingdom | Milton Keynes University Hospital | Milton Keynes |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Coventry and Warwickshire NHS Trust | University of Leeds, University of Manchester, University of Warwick |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic accuracy of stool FIT plus urine VOC compared to stool FIT alone to improve detection of SBD. | Sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of stool FIT plus urine VOC in detection of SBD, using colonoscopy histology findings. | 24 months | |
Secondary | Diagnostic accuracy of stool FIT plus urine VOC in detection of SBD | Receiver operating characteristic (ROC) curve of stool FIT plus urine VOC in detection of SBD to optimise the detection threshold. | 24 months | |
Secondary | Impact on number of colonoscopies undertaken | Calculation of potential number of colonoscopies avoided in those without SBD. | 24 months | |
Secondary | Cost effectiveness and colonoscopy disutility | Cost calculation, Quality of life (EQ-5D-5L) and quality adjusted life years (QALY) associated with utility of each diagnostic strategy (stool FIT and urine VOC) will be assessed to create a model that will employ a multi-part structure, consisting of a decision tree to evaluate short-term cost and consequences accruing at the diagnosis stage followed by a state-transition model to capture the long-term (lifetime) outcomes associated with the diagnosed condition. | 24 months |
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