Crohn Disease in RemissionSCUBANCT04321863
Stratifying Crohn's Using Biomarker Assessment
An observational study of Crohn Disease in Remission, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
Crohn's disease (CD) is a relapsing-remitting condition that requires lifelong monitoring. Non-invasive tests such as faecal calprotectin (FC) are more acceptable to patients and cost-effective than invasive tests such as colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Crohn Disease in Remission
- What is being tested?
- Faecal calprotectin (FC), quantitative Faecal Immunochemical Testing (qFIT) and Serum and faecal zinc
- How many people
- 315 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Aug 2020to 1 Jul 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with quiescent (inactive) luminal Crohn's disease attending secondary care clinic.
Who may be able to join
- Confirmed diagnosis of luminal CD by standard endoscopic, histological or radiological criteria
- In clinical remission as defined by Harvey Bradshaw Index (HBI) <4
- Aged 18-50
- On any CD-related therapy or indeed no therapy
- Having FC checked anyway to monitor mucosal disease activity
Who cannot join
- Isolated perianal or upper GI CD
- Short gut syndrome necessitating total parenteral nutrition (TPN); otherwise patients with stomas allowed.
- Current or previous colorectal carcinoma or high-risk adenoma, active diverticular disease (diverticulitis) or haemorrhoids
- Ulcerative or indeterminate colitis
- Patients taking NSAIDs, warfarin, heparin, anti-platelet therapy or DOACs.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Glasgow Royal Infirmary
Glasgow, G40SF
Daniel Gaya, MBChB, daniel.gaya@ggc.scot.nhs.uk
Jennifwe Veryan, MBChB, jen.veryan@lanarkshire.scot.nhs.uk
About this study
Crohn's disease (CD) is a relapsing-remitting condition that requires lifelong monitoring. Non-invasive tests such as faecal calprotectin (FC) are more acceptable to patients and cost-effective than invasive tests such as colonoscopy.
FC levels can also accurately predict the degree of healing seen within the bowel at colonoscopy.
Read more
FC testing is labour intensive, and results are often indeterminate. There is interest in a newer test called quantitative Faecal Immunochemical Testing (qFIT) in patients with CD. qFIT measures the amount of blood within the stool and is used in the Scottish Bowel Cancer Screening Programme. qFIT is an easier and more acceptable test for patients and is less labour intensive and cheaper for the lab to process than FC.
qFIT is a useful test to 'rule-out' significant colorectal pathology including bowel cancer, high risk polyps and inflammatory bowel disease in patients in the primary care setting. It has also been used to predict the degree of healing seen within the bowel at colonoscopy and to predict the risk of relapse in patients with UC, but not in CD. There are no studies in the UK to date comparing FIT to FC as a monitoring test in patients with well-controlled CD.
Unpublished audit data from our group has suggested that low serum zinc has higher predictive accuracy at determining risk of future flare than both FC and CRP; we are unsure if this is due to higher faecal losses in 'grumbling' CD patients.
This study could identify a cheaper, more acceptable and easier to interpret test to guide disease activity monitoring, flare risk and treatment decisions in quiescent CD.
Read the detailed description
Crohn's disease (CD) is a relapsing and remitting condition requiring lifelong monitoring.
Stool sampling for disease monitoring in inflammatory bowel disease (IBD) is non-invasive, cost-effective and acceptable to patients. Faecal calprotectin (FC) and quantitative Faecal Immunochemical Testing (qFIT) are both stool-based tests.
FC is a surrogate marker of neutrophil influx into the gut lumen. It accurately predicts mucosal healing (MH) at colonoscopy, and thus FC is already widely used in clinical practice in disease monitoring in CD patients.
qFIT, testing stool for haemoglobin, has been used in the Scottish Bowel Cancer Screening Programme since November 2017. A 'negative' qFIT is also a useful 'rule-out' test for significant colorectal pathology (including colorectal cancer, high-risk adenomas and IBD) in primary care. qFIT has been shown to predict MH in both CD and ulcerative colitis (UC), and has been used to predict relapse in patients with UC but not CD. There is no UK study to date comparing the ability of qFIT and FC to predict flare in CD.
qFIT is a cheaper, more stable test with a quicker turn-around time than FC. It is also less labour intensive for the lab.
CRP is a cheap and easily available biomarker but is insensitive, non-specific and inferior to FC at predicting relapse in CD. CRP can also be elevated by infective complications or other concomitant inflammatory disease which makes its interpretation difficult. New data from our group has suggested that low serum zinc has higher predictive accuracy at determining risk of future flare than both FC and CRP; we are unsure if this is due to higher faecal losses in 'grumbling' CD patients.
This observational, prospective cohort study will recruit patients with luminal (affecting small and/or large bowel) CD in clinical remission (i.e. asymptomatic). A stool sample will be used to check a qFIT and faecal zinc in addition to the routinely monitored FC. At the time of routine blood collection, an additional sample will be taken to check plasma zinc. CRP is already checked routinely.
Patients will be followed up for one year, or until flare/relapse - this information will be accessed remotely through electronic patient records.
The ability of qFIT, serum zinc and faecal zinc to predict relapse in CD will be compared to FC using area under the ROC curve (AUC).
Primary study aim:
To compare the ability of qFIT and FC at predicting relapse/flare in patients with quiescent (inactive) luminal (affecting the small and large bowel) CD.
Relapse (or flare) is defined as the need for new or additional treatment for CD, hospitalisation for CD, or CD related surgery.
Primary hypothesis:
qFIT is not inferior to FC at predicting flare in quiescent (inactive) luminal (affecting the small and large bowel) CD.
Secondary study aim:
Compare the ability of serum/faecal zinc and CRP at predicting relapse in patients with quiescent (inactive) luminal (affecting the small and/or large bowel) CD.
Secondary hypothesis:
Serum/faecal zinc is superior to CRP at predicting relapse/flare in patients with quiescent (inactive) luminal (affecting the small and large bowel) CD.
- Conditions
- Crohn Disease in Remission
- Being tested
- Faecal calprotectin (FC), quantitative Faecal Immunochemical Testing (qFIT), Serum and faecal zinc
- Keywords
- Faecal biomarkers, Serum biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faecal calprotectin (FC)Other
FC is a surrogate marker of neutrophil influx into the gut lumen. It accurately predicts mucosal healing (MH) at colonoscopy, and thus is already widely used in clinical practice in disease monitoring in CD patients (standard of care).
quantitative Faecal Immunochemical Testing (qFIT)Other
Stool test for haemoglobin. It has been shown to predict mucosal healing in Crohn's disease and ulcerative colitis. This study will compare the ability of qFIT and FC to predict flare in CD (qFIT is a cheaper, more stable test with a quicker turn-around time than FC, and is also less labour intensive for the lab).
Serum and faecal zincOther
Blood sample for serum zinc will be taken at same time as routine (standard of care) monitoring bloods which include CRP - no additional venipuncture will be required. A single stool sample will be sufficient to measure FC (as outlines above) and faecal zinc. This study will compare the ability of serum/faecal zinc and CRP at predicting relapse in patients with quiescent (inactive) luminal (affecting the small and/or large bowel) CD.
| Study group | Role | What they receive |
|---|---|---|
| Adults with Crohn's disease in remission | All patients recruited will submit two samples to facilitate faecal zinc and qFIT in addition to FC which is standard of care. All patients recruited will have an additional tube of blood taken to measure serum zinc at the same time as they have their routine (standard of care) monitoring bloods taken - no additional venepuncture will be required. Receives: Other: Faecal calprotectin (FC); Other: quantitative Faecal Immunochemical Testing (qFIT); Other: Serum and faecal zinc |
What is being measured
The primary outcome is the main question the study is designed to answer.
qFIT and FC
To compare the ability of qFIT and FC at predicting relapse/flare in patients with quiescent (inactive) luminal (affecting the small and large bowel) CD.
Relapse (or flare) is defined as the need for new or additional treatment for CD, hospitalisation for CD, or CD related surgery.
The ability of qFIT to predict relapse in CD will be compared to FC using area under the ROC curve (AUC).
Measured: 1 year
Secondary outcomes (1)
Serum/faecal zinc
Compare the ability of serum/faecal zinc and CRP at predicting relapse in patients with quiescent (inactive) luminal (affecting the small and/or large bowel) CD. Relapse (or flare) is defined as the need for new or additional treatment for CD, hospitalisation for CD, or CD related surgery.
The ability of serum zinc and faecal zinc to predict relapse in CD will be compared to FC using area under the ROC curve (AUC).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start13 Aug 2020
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease in RemissionStudies 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
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321863
- Sponsor's protocol ID
- 20/WS/0028
- Other IDs
- 246230
- Acronym
- SCUBA
- Status last verified
- Oct 2020
- First submitted
- 23 Mar 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stratifying Crohn's Using Biomarker Assessment
- ClinicalTrials.gov ID
- NCT04321863
- Acronym / sponsor ID
- SCUBA / 20/WS/0028
- Conditions
- Crohn Disease in Remission
- Keywords
- Faecal biomarkers, Serum biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 25 Mar 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.
Crohn's disease (CD) is a relapsing-remitting condition that requires lifelong monitoring. Non-invasive tests such as faecal calprotectin (FC) are more acceptable to patients and cost-effective than invasive tests such as colonoscopy.
FC levels can also accurately predict the degree of healing seen within the bowel at colonoscopy.
FC testing is labour intensive, and results are often indeterminate. There is interest in a newer test called quantitative Faecal Immunochemical Testing (qFIT) in patients with CD. qFIT measures the amount of blood within the stool and is used in the Scottish Bowel Cancer Screening Programme. qFIT is an easier and more acceptable test for patients and is less labour intensive and cheaper for the lab to process than FC.
qFIT is a useful test to 'rule-out' significant colorectal pathology including bowel cancer, high risk polyps and inflammatory bowel disease in patients in the primary care setting. It has also been used to predict the degree of healing seen within the bowel at colonoscopy and to predict the risk of relapse in patients with UC, but not in CD. There are no studies in the UK to date comparing FIT to FC as a monitoring test in patients with well-controlled CD.
Unpublished audit data from our group has suggested that low serum zinc has higher predictive accuracy at determining risk of future flare than both FC and CRP; we are unsure if this is due to higher faecal losses in 'grumbling' CD patients.
This study could identify a cheaper, more acceptable and easier to interpret test to guide disease activity monitoring, flare risk and treatment decisions in quiescent CD.
Detailed description
Crohn's disease (CD) is a relapsing and remitting condition requiring lifelong monitoring.
Stool sampling for disease monitoring in inflammatory bowel disease (IBD) is non-invasive, cost-effective and acceptable to patients. Faecal calprotectin (FC) and quantitative Faecal Immunochemical Testing (qFIT) are both stool-based tests.
FC is a surrogate marker of neutrophil influx into the gut lumen. It accurately predicts mucosal healing (MH) at colonoscopy, and thus FC is already widely used in clinical practice in disease monitoring in CD patients.
qFIT, testing stool for haemoglobin, has been used in the Scottish Bowel Cancer Screening Programme since November 2017. A 'negative' qFIT is also a useful 'rule-out' test for significant colorectal pathology (including colorectal cancer, high-risk adenomas and IBD) in primary care. qFIT has been shown to predict MH in both CD and ulcerative colitis (UC), and has been used to predict relapse in patients with UC but not CD. There is no UK study to date comparing the ability of qFIT and FC to predict flare in CD.
qFIT is a cheaper, more stable test with a quicker turn-around time than FC. It is also less labour intensive for the lab.
CRP is a cheap and easily available biomarker but is insensitive, non-specific and inferior to FC at predicting relapse in CD. CRP can also be elevated by infective complications or other concomitant inflammatory disease which makes its interpretation difficult. New data from our group has suggested that low serum zinc has higher predictive accuracy at determining risk of future flare than both FC and CRP; we are unsure if this is due to higher faecal losses in 'grumbling' CD patients.
This observational, prospective cohort study will recruit patients with luminal (affecting small and/or large bowel) CD in clinical remission (i.e. asymptomatic). A stool sample will be used to check a qFIT and faecal zinc in addition to the routinely monitored FC. At the time of routine blood collection, an additional sample will be taken to check plasma zinc. CRP is already checked routinely.
Patients will be followed up for one year, or until flare/relapse - this information will be accessed remotely through electronic patient records.
The ability of qFIT, serum zinc and faecal zinc to predict relapse in CD will be compared to FC using area under the ROC curve (AUC).
Primary study aim:
To compare the ability of qFIT and FC at predicting relapse/flare in patients with quiescent (inactive) luminal (affecting the small and large bowel) CD.
Relapse (or flare) is defined as the need for new or additional treatment for CD, hospitalisation for CD, or CD related surgery.
Primary hypothesis:
qFIT is not inferior to FC at predicting flare in quiescent (inactive) luminal (affecting the small and large bowel) CD.
Secondary study aim:
Compare the ability of serum/faecal zinc and CRP at predicting relapse in patients with quiescent (inactive) luminal (affecting the small and/or large bowel) CD.
Secondary hypothesis:
Serum/faecal zinc is superior to CRP at predicting relapse/flare in patients with quiescent (inactive) luminal (affecting the small and large bowel) CD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with Crohn's disease in remission | – | Other: Faecal calprotectin (FC), Other: quantitative Faecal Immunochemical Testing (qFIT), Other: Serum and faecal zincAll patients recruited will submit two samples to facilitate faecal zinc and qFIT in addition to FC which is standard of care. All patients recruited will have an additional tube of blood taken to measure serum zinc at the same time as they have their routine (standard of care) monitoring bloods taken - no additional venepuncture will be required. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with quiescent (inactive) luminal Crohn's disease attending secondary care clinic.
Key inclusion criteria (5 listed)
- Confirmed diagnosis of luminal CD by standard endoscopic, histological or radiological criteria
- In clinical remission as defined by Harvey Bradshaw Index (HBI) <4
- Aged 18-50
- On any CD-related therapy or indeed no therapy
- Having FC checked anyway to monitor mucosal disease activity
Key exclusion criteria (5 listed)
- Isolated perianal or upper GI CD
- Short gut syndrome necessitating total parenteral nutrition (TPN); otherwise patients with stomas allowed.
- Current or previous colorectal carcinoma or high-risk adenoma, active diverticular disease (diverticulitis) or haemorrhoids
- Ulcerative or indeterminate colitis
- Patients taking NSAIDs, warfarin, heparin, anti-platelet therapy or DOACs.
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 |
|---|---|---|
| Faecal calprotectin (FC)FC is a surrogate marker of neutrophil influx into the gut lumen. It accurately predicts mucosal healing (MH) at colonoscopy, and thus is already widely used in clinical practice in disease monitoring in CD patients (standard of care). | Other | Adults with Crohn's disease in remission |
| quantitative Faecal Immunochemical Testing (qFIT)Stool test for haemoglobin. It has been shown to predict mucosal healing in Crohn's disease and ulcerative colitis. This study will compare the ability of qFIT and FC to predict flare in CD (qFIT is a cheaper, more stable test with a quicker turn-around time than FC, and is also less labour intensive for the lab). | Other | Adults with Crohn's disease in remission |
| Serum and faecal zincBlood sample for serum zinc will be taken at same time as routine (standard of care) monitoring bloods which include CRP - no additional venipuncture will be required. A single stool sample will be sufficient to measure FC (as outlines above) and faecal zinc. This study will compare the ability of serum/faecal zinc and CRP at predicting relapse in patients with quiescent (inactive) luminal (affecting the small and/or large bowel) CD. | Other | Adults with Crohn's disease in remission |
Primary outcome
qFIT and FC
Time frame: 1 year
To compare the ability of qFIT and FC at predicting relapse/flare in patients with quiescent (inactive) luminal (affecting the small and large bowel) CD. Relapse (or flare) is defined as the need for new or additional treatment for CD, hospitalisation for CD, or CD related surgery. The ability of qFIT to predict relapse in CD will be compared to FC using area under the ROC curve (AUC).
1 secondary outcome
Serum/faecal zinc
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease in Remission, run by NHS Greater Glasgow and Clyde at 1 site 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel R Gaya, MBChB (hons), FRCP (Glasg) (0141-211-4290, daniel.gaya@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
qFIT and FC (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2020.