University Hospitals Coventry & Warwickshire NHS Trust
Coventry, CV2 2DX, United Kingdom
NCT Number: NCT04146662
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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Notify Me18 year and older
All sexes
Observational
Coventry, CV2 2DX, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Faecal immunochemical test (FIT) and urine volatile organic compounds (VOC) analysis.
Other names: Urine volatile organic compounds
Time frame: Through study completion, an average of 2 years
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).
Time frame: Through study completion, an average of 2 years
To determine the specificity and receiver operator curve for Faecal immunochemical test and urine volatile markers for all adenomas and high-grade adenomas.
Time frame: Through study completion, an average of 2 years
To determine the positivity threshold for FIT and urine VOC for detection of adenomas, comparing all adenomas vs high grade adenomas.
Time frame: Through study completion, an average of 2 years
To identify the specific volatile chemicals that are consistently present in those with adenomas.
Time frame: Through study completion, an average of 2 years
To determine the sensitivity of blood markers e.g. Septin 9 for the detection of colorectal adenomas
University Hospitals Coventry and Warwickshire NHS Trust
Other
The Performance of Faecal Immunochemical Test and Urinary Volatile Compounds in the Detection of Colorectal Adenomas and Their Role in Polyp Surveillance
Acronym: FASt
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