Colorectal CancerRECEDENCT04516785
Reducing Colonoscopies in Patients Without Significant Bowel Disease
An observational study of Colorectal Cancer and Colorectal Disorders, run by University Hospitals Coventry and Warwickshire NHS Trust at 4 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal Cancer, Colorectal Disorders, Colorectal Adenoma
- What is being tested?
- FIT and VOC
- How many people
- 1,181 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 17 Sep 2020to 17 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- - 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
Who cannot join
- Those who are pregnant
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
University Hospital Coventry and Warwickshire NHS Trust
Coventry, West Midlands, CV22DX
University Hospital Derby & Burton
Derby, DE223NE
East Cheshire NHS Trust
Macclesfield, SK103BL
Milton Keynes University Hospital
Milton Keynes, MK65LD
About this study
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.
Read more
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.
Read the detailed description
There is currently disparity between demand and available resources for colonoscopy. At present around 300,000 participants (and rising) are being referred annually to NHS trusts suspected of colorectal cancer (CRC). These participants are offered invasive colonic examinations (colonoscopy or CT colonography) but only 30% will have significant bowel disease. Significant bowel disease includes neoplasia (cancer and benign tumours) and significant treatable benign conditions such as inflammatory bowel disease and microscopic colitis. Of the remaining 70%, 40% have completely normal colonic investigations and 30% have functional bowel conditions such as irritable bowel syndrome or diverticular disease.
Set against this there is and will remain for the foreseeable future a capacity shortfall for colonoscopy. This limits the ability of the NHS to extend colorectal cancer detection within the Bowel Cancer Screening Programme (BCSP) or to target those participants that present for the first time through the Emergency Department (25% of all colorectal cancer diagnoses).
The increasing demand, limited capacity and lack of a triage tests have left NHS trusts with a conundrum of how best to stratify those with symptoms and at risk of SBD including CRC. The National Institute for Health and Care Excellence (NICE) has recommended a stool test (faecal immunochemical testing for haemoglobin, known as FIT) in the assessment of those suspected of CRC. NICE have recommended 10 μgHb/g faeces as the cut off for investigation of people with low risk symptoms who, account for only 10% of those referred with suspected CRC. When applied to high risk symptom groups, FIT will miss a significant number of participants with CRC (~10%) if used on its own at the threshold recommended by NICE (10 μgHb/g faeces). FIT will also miss a large number of significant potentially pre-cancerous polyps (~40%). Early detection and removal of such polyps will reduce risk of CRC.
The Bowel Cancer Screening Programme (BCSP) has set a FIT cut off of >120 μgHb/g faeces, compared to the NICE threshold of 10 μgHb/g faeces, but even at the lower threshold recommended by NICE some SBDs will be missed. Whilst a lower threshold might improve detection of SBD, it will increase the number of colonoscopies that find no abnormality. Consequently, the investigators have been investigating a urine test (in addition to FIT) to improve detection of participants with SBD with a view to reducing unnecessary colonoscopies. The urine test analyses volatile organic compounds (VOCs) that originate from the body and provides a chemical 'fingerprint' that is disease specific. Stool FIT and urine VOCs identify different biological characteristics of SBD - haemoglobin (as a marker of excess blood loss) versus metabolic response to inflammation. In a preliminary study of 562 participants, stool FIT on its own (at a threshold determined from the data) detected 80% of those with colorectal cancer. However, the addition of urine chemical testing improved this to 97%. The number of CRC cases missed by combined FIT and urine chemical testing is similar to that of colonoscopy, the current gold standard.
- Being tested
- FIT and VOC
- Keywords
- gastroenterology, colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIT and VOCDiagnostic test
Stool sample (FIT) analysed for blood in faeces and urine sample (VOC) analysed for the presence of volatile organic compounds
| Study group | Role | What they receive |
|---|---|---|
| Intervention | FIT and urine VOC samples followed by colonoscopy Receives: Diagnostic Test: FIT and VOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (3)
Diagnostic accuracy of stool FIT plus urine VOC in detection of SBD
Receiver operating characteristic (ROC) curve of stool FIT plus urine VOC in detection of SBD to optimise the detection threshold.
Measured: 24 months
Impact on number of colonoscopies undertaken
Calculation of potential number of colonoscopies avoided in those without SBD.
Measured: 24 months
Cost effectiveness and colonoscopy disutility
Cost calculation, Quality of life (EQ-5D-5L) and quality adjusted life years (QALY) associated with utility of each diagnostic strategy (stool FIT and urine VOC) will be assessed to create a model that will employ a multi-part structure, consisting of a decision tree to evaluate short-term cost and consequences accruing at the diagnosis stage followed by a state-transition model to capture the long-term (lifetime) outcomes associated with the diagnosed condition.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start17 Sep 2020
- Primary completion17 Nov 2022
- Study completion17 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,181 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Warwick, University of Leeds, University of Manchester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516785
- Sponsor's protocol ID
- RA481020
- Acronym
- RECEDE
- Status last verified
- Jun 2024
- First submitted
- 13 Aug 2020
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35354626
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Colonoscopies in Patients Without Significant Bowel Disease
- ClinicalTrials.gov ID
- NCT04516785
- Acronym / sponsor ID
- RECEDE / RA481020
- Keywords
- gastroenterology, colonoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,181 participants (actual)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Collaborators
- University of Warwick, University of Leeds, University of Manchester
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There is currently disparity between demand and available resources for colonoscopy. At present around 300,000 participants (and rising) are being referred annually to NHS trusts suspected of colorectal cancer (CRC). These participants are offered invasive colonic examinations (colonoscopy or CT colonography) but only 30% will have significant bowel disease. Significant bowel disease includes neoplasia (cancer and benign tumours) and significant treatable benign conditions such as inflammatory bowel disease and microscopic colitis. Of the remaining 70%, 40% have completely normal colonic investigations and 30% have functional bowel conditions such as irritable bowel syndrome or diverticular disease.
Set against this there is and will remain for the foreseeable future a capacity shortfall for colonoscopy. This limits the ability of the NHS to extend colorectal cancer detection within the Bowel Cancer Screening Programme (BCSP) or to target those participants that present for the first time through the Emergency Department (25% of all colorectal cancer diagnoses).
The increasing demand, limited capacity and lack of a triage tests have left NHS trusts with a conundrum of how best to stratify those with symptoms and at risk of SBD including CRC. The National Institute for Health and Care Excellence (NICE) has recommended a stool test (faecal immunochemical testing for haemoglobin, known as FIT) in the assessment of those suspected of CRC. NICE have recommended 10 μgHb/g faeces as the cut off for investigation of people with low risk symptoms who, account for only 10% of those referred with suspected CRC. When applied to high risk symptom groups, FIT will miss a significant number of participants with CRC (~10%) if used on its own at the threshold recommended by NICE (10 μgHb/g faeces). FIT will also miss a large number of significant potentially pre-cancerous polyps (~40%). Early detection and removal of such polyps will reduce risk of CRC.
The Bowel Cancer Screening Programme (BCSP) has set a FIT cut off of >120 μgHb/g faeces, compared to the NICE threshold of 10 μgHb/g faeces, but even at the lower threshold recommended by NICE some SBDs will be missed. Whilst a lower threshold might improve detection of SBD, it will increase the number of colonoscopies that find no abnormality. Consequently, the investigators have been investigating a urine test (in addition to FIT) to improve detection of participants with SBD with a view to reducing unnecessary colonoscopies. The urine test analyses volatile organic compounds (VOCs) that originate from the body and provides a chemical 'fingerprint' that is disease specific. Stool FIT and urine VOCs identify different biological characteristics of SBD - haemoglobin (as a marker of excess blood loss) versus metabolic response to inflammation. In a preliminary study of 562 participants, stool FIT on its own (at a threshold determined from the data) detected 80% of those with colorectal cancer. However, the addition of urine chemical testing improved this to 97%. The number of CRC cases missed by combined FIT and urine chemical testing is similar to that of colonoscopy, the current gold standard.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Diagnostic Test: FIT and VOCFIT and urine VOC samples followed by colonoscopy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- - 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
Key exclusion criteria (1 listed)
- Those who are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FIT and VOCStool sample (FIT) analysed for blood in faeces and urine sample (VOC) analysed for the presence of volatile organic compounds | Diagnostic test | Intervention |
Primary outcome
Diagnostic accuracy of stool FIT plus urine VOC compared to stool FIT alone to improve detection of SBD.
Time frame: 24 months
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.
3 secondary outcomes
Diagnostic accuracy of stool FIT plus urine VOC in detection of SBD
Time frame: 24 months
Impact on number of colonoscopies undertaken
Time frame: 24 months
Cost effectiveness and colonoscopy disutility
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Derived from this study: PubMed 35354626Bradley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Colorectal Disorders, run by University Hospitals Coventry and Warwickshire NHS Trust at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of stool FIT plus urine VOC compared to stool FIT alone to improve detection of SBD. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04516785, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.