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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faecal immunochemical test | Diagnostic Test | Faecal immunochemical test (FIT) and urine volatile organic compounds (VOC) analysis. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adults over 18 years who are known to have colorectal polyps and on polyp surveillance programme
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Coventry & Warwickshire NHS Trust | Coventry | CV2 2DX | United Kingdom |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Urine, Stool, and Blood
| 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 |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |