Faecal Immunochemical Test and Urine Volatile Compounds in Adenoma Detection

Colorectal Cancer Clinical Trial

— FASt  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04146662
• Other study ID #: RA433019
• Status: Completed
• Start date: October 16, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: June 2024
• Source: University Hospitals Coventry and Warwickshire NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: March 31, 2022
• Est. primary completion date: March 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colorectal Cancer

Intervention

Diagnostic Test:
• Faecal immunochemical test
Faecal immunochemical test (FIT) and urine volatile organic compounds (VOC) analysis.

Locations

Country	Name	City	State
United Kingdom	University Hospitals Coventry & Warwickshire NHS Trust	Coventry

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Coventry and Warwickshire NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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