Faecal Immunochemical Test and Urine Volatile Compounds in Adenoma Detection

NCT04146662 | Completed

• 1 other identifier: RA433019
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

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).

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Sensitivity of Faecal immunochemical test and urine volatile markers for all adenomas and high-grade adenomas

  Through study completion, an average of 2 years

• Positivity threshold for Faecal immunochemical test and urine volatile markers

  Through study completion, an average of 2 years

• Volatile chemicals in urine 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

  Through study completion, an average of 2 years

Interventions

Faecal immunochemical test DIAGNOSTIC_TEST

Faecal immunochemical test (FIT) and urine volatile organic compounds (VOC) analysis.

Also known as: Urine volatile organic compounds

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults over 18 years who are known to have colorectal polyps and on polyp surveillance programme

You may qualify if:

• 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.

You may not qualify if:

• Participants who are unable to attend colonoscopy
• Under 18 years old
• Unable to provide informed consent for themselves to take part in this study

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead

Study Sites (1)

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, CV2 2DX, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine, Stool, and Blood

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 31, 2019
• Study Start: October 16, 2019
• Primary Completion: March 23, 2021
• Study Completion: March 31, 2022
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

GB (1)