Stratifying Crohn's Using Biomarker Assessment
SCUBA
2 other identifiers
observational
315
1 country
1
Brief 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. 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 Unpublished audit data from our group has suggested that low serum zinc has higher predictive accuracy at determining risk of future flare than both FC and CRP; we are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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2020
CompletedFirst Posted
Study publicly available on registry
March 25, 2020
CompletedStudy Start
First participant enrolled
August 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedOctober 8, 2020
October 1, 2020
11 months
March 23, 2020
October 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
1 year
Secondary Outcomes (1)
Serum/faecal zinc
1 year
Study Arms (1)
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.
Interventions
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).
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).
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.
Eligibility Criteria
Patients with quiescent (inactive) luminal Crohn's disease attending secondary care clinic.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Glasgow Royal Infirmary
Glasgow, G40SF, United Kingdom
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2020
First Posted
March 25, 2020
Study Start
August 13, 2020
Primary Completion
July 1, 2021
Study Completion
July 1, 2022
Last Updated
October 8, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share