Faecal Immunochemical Test and Urine Volatile Compounds in Adenoma Detection

Study Overview
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Brief Summary
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Bowel cancer can arise from polyps, which can become cancerous. Polyps are little outgrowths within the lining of the bowel (similar to skin warts). Depending on their size and their potential to become cancerous, they can cause bleeding. However, it is not known which polyps harbour cancerous potential. Therefore, at present all patients undergo a colonoscopy (camera examination of the large bowel) in order to identify and remove any polyps. However, not all patients who undergo a colonoscopy will have polyps. Moreover, colonoscopies are invasive and disruptive to patients, as they require bowel preparation. The aim of this study is to evaluate non-invasive stool and urine tests to identify patients who are at risk of polyps and if the polyps have the potential to become cancerous. This in turn, will significantly reduce the number of 'unnecessary' polyp surveillance colonoscopies with resultant benefits to both patients and the National Health Service (NHS).

Official Title
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The Performance of Faecal Immunochemical Test and Urinary Volatile Compounds in the Detection of Colorectal Adenomas and Their Role in Polyp Surveillance

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Diagnostic Test: Faecal immunochemical test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are on a polyp surveillance programme and will be undergoing colonoscopy examination for polyp surveillance OR Patients who will be undergoing elective polypectomy through specialised polyp multi-disciplinary meetings. Exclusion Criteria: Participants who are unable to attend colonoscopy Under 18 years old Unable to provide informed consent for themselves to take part in this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Faecal immunochemical test|Faecal immunochemical test (FIT) and urine volatile organic compounds (VOC) analysis.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of Faecal immunochemical test and urine volatile markers to detect colorectal adenomas | To determine the sensitivity of Faecal immunochemical test and urine volatile markers to detect colorectal adenomas - individually and in combination, in comparison to colonoscopy results (histology findings). | Through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of Faecal immunochemical test and urine volatile markers for all adenomas and high-grade adenomas | To determine the specificity and receiver operator curve for Faecal immunochemical test and urine volatile markers for all adenomas and high-grade adenomas. | Through study completion, an average of 2 years | 
| Positivity threshold for Faecal immunochemical test and urine volatile markers | To determine the positivity threshold for FIT and urine VOC for detection of adenomas, comparing all adenomas vs high grade adenomas. | Through study completion, an average of 2 years | 
| Volatile chemicals in urine in those with adenomas | To identify the specific volatile chemicals that are consistently present in those with adenomas. | Through study completion, an average of 2 years | 
| To determine the sensitivity of blood markers for the detection of colorectal adenomas | To determine the sensitivity of blood markers e.g. Septin 9 for the detection of colorectal adenomas | Through study completion, an average of 2 years |