Faecal Immunochemical Test and Urine Volatile Compounds in Adenoma Detection

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT04146662
• Lead Sponsor: University Hospitals Coventry and Warwickshire NHS Trust

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-10
• Study Start: 2019-10-16
• Study First Submitted QC: 2019-10-30
• Study First Posted: 2019-10-31
• Primary Completion: 2021-03-23
• Study Completion: 2022-03-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of Faecal immunochemical test and urine volatile markers to detect colorectal adenomas	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).

Secondary Outcome Measures

Name	Time	Method
Positivity threshold for Faecal immunochemical test and urine volatile markers	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.
Volatile chemicals in urine in those with adenomas	Through study completion, an average of 2 years	To identify the specific volatile chemicals that are consistently present in those with adenomas.
Sensitivity of Faecal immunochemical test and urine volatile markers for all adenomas and high-grade adenomas	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.
To determine the sensitivity of blood markers for the detection of colorectal adenomas	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

Trial Locations

Locations (1)

University Hospitals Coventry & Warwickshire NHS Trust; 🇬🇧 Coventry, United Kingdom