Reducing Colonoscopies in Patients Without Significant Bowel Disease

NCT04516785 | Completed

• 1 other identifier: RA481020
• Study Type: observational
• Target: 1,181
• Locations: 1 country
• Sites: 4

Brief Summary

Investigating people with bowel symptoms uses a test that detects traces of blood in the stools, the FIT test. There are many possible reasons for positive tests. A few people have cancer. However, most participants with symptoms don't have any serious bowel disease but have benign problems such as piles or irritable bowel syndrome (IBS). It is very difficult to diagnose on symptoms alone, those participants who have serious bowel disease and those who do not. After a positive test, people are invited for colonoscopy - a sort of articulated tube that is passed up the bowel. Most people invited for colonoscopy don't have cancer. Only about 5% of those with positive FIT tests have cancer. About 25% have other bowel diseases, but most have nothing serious wrong at all. So they have the inconvenience and discomfort of colonoscopy but don't get any benefit from it. The investigators want to try adding another test, the volatile organic compound (VOC) test, to see if the investigators can separate those with positive FIT tests who do have something wrong, from those who don't. The VOC test uses a urine sample. Using both tests might also be better for detecting cancer. FIT alone misses about 20%. So the investigators think that using both tests might not only be better for detecting cancer, but also might mean that a lot of people will avoid having to have colonoscopy. This study will recruit 1,819 participants with bowel symptoms from NHS trusts in the UK. They will provide stool samples for FIT and urine for VOC analysis. They will have colonoscopy to get a definite diagnosis. Then the investigators will look at their FIT and VOC test results to see if in future, people with both tests negative.

Conditions

Colorectal Cancer; Colorectal Disorders; Colorectal Adenoma; Colorectal Polyp

Keywords

gastroenterology; colonoscopy

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of stool FIT plus urine VOC compared to stool FIT alone to improve detection of SBD.

  Sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of stool FIT plus urine VOC in detection of SBD, using colonoscopy histology findings.

  24 months

Secondary Outcomes (3)

• Diagnostic accuracy of stool FIT plus urine VOC in detection of SBD

  24 months

• Impact on number of colonoscopies undertaken

  24 months

• Cost effectiveness and colonoscopy disutility

  24 months

Study Arms (1)

Intervention

FIT and urine VOC samples followed by colonoscopy

Diagnostic Test: FIT and VOC

Interventions

FIT and VOC DIAGNOSTIC_TEST

Stool sample (FIT) analysed for blood in faeces and urine sample (VOC) analysed for the presence of volatile organic compounds

Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants referred either routinely with lower gastrointestinal symptoms or urgently (fulfilling the national criteria for referral - NICE NG12) for colonoscopy investigation that is determined by their overseeing clinician

You may qualify if:

• \- All participants referred either routinely with lower gastrointestinal symptoms or urgently (fulfilling the national criteria for referral - NICE NG12) for colonoscopy investigation that is determined by their overseeing clinician
• Minimum age of 18
• Able to provide informed consent
• Have the ability to return both stool and urine samples

You may not qualify if:

• Those who are pregnant

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead
• University of Warwick: collaborator
• University of Leeds: collaborator
• University of Manchester: collaborator

Study Sites (4)

University Hospital Coventry and Warwickshire NHS Trust

Coventry, West Midlands, CV22DX, United Kingdom

Location

University Hospital Derby & Burton

Derby, DE223NE, United Kingdom

Location

East Cheshire NHS Trust

Macclesfield, SK103BL, United Kingdom

Location

Milton Keynes University Hospital

Milton Keynes, MK65LD, United Kingdom

Location

Related Publications (1)

• Bradley C, Hee SW, Andronis L, Persaud K, Hull MA, Todd J, Taylor-Phillips S, Smith S, Constable R, Waugh N, Arasaradnam RP; RECEDE Study Group. REducing Colonoscopies in patients without significant bowEl DiseasE: the RECEDE Study - protocol for a prospective diagnostic accuracy study. BMJ Open. 2022 Mar 30;12(3):e058559. doi: 10.1136/bmjopen-2021-058559.

  PMID: 35354626 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool and urine samples

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: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 18, 2020
• Study Start: September 17, 2020
• Primary Completion: November 17, 2022
• Study Completion: November 17, 2022
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)