SCUBA (Stratifying Crohn's Using Biomarker Assessment)
Research type
Research Study
Full title
Stratifying Crohn's Using Biomarker Assessment (SCUBA).
IRAS ID
246230
Contact name
Daniel Gaya
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 26 days
Research summary
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).
REC name
West of Scotland REC 4
REC reference
20/WS/0028
Date of REC Opinion
13 Feb 2020
REC opinion
Favourable Opinion