Clinical trial NCT04146662: Faecal Immunochemical Test and Urine Volatile Compounds in Adenoma Detection
Official title: The Performance of Faecal Immunochemical Test and Urinary Volatile Compounds in the Detection of Colorectal Adenomas and Their Role in Polyp Surveillance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: University Hospitals Coventry and Warwickshire NHS Trust
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults over 18 years who are known to have colorectal polyps and on polyp surveillance programme

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of Faecal immunochemical test and urine volatile markers to detect colorectal adenomas
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Sensitivity of Faecal immunochemical test and urine volatile markers for all adenomas and high-grade adenomas
timeFrame: Through study completion, an average of 2 years
measure: Positivity threshold for Faecal immunochemical test and urine volatile markers
timeFrame: Through study completion, an average of 2 years
measure: Volatile chemicals in urine in those with adenomas
timeFrame: Through study completion, an average of 2 years
measure: To determine the sensitivity of blood markers for the detection of colorectal adenomas
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry & Warwickshire NHS Trust
Study officials:
References: