CROCO- Crohn's Disease Cohort Study
Research type
Research Study
Full title
The CROCO Study- CROhn's disease COhort study
IRAS ID
284239
Contact name
Shaji Sebastian
Contact email
Sponsor organisation
Learning Health
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
Crohn's disease (CD) is a chronic inflammatory disease of unknown cause. Chronic inflammation predisposes to bowle complications including strictures (narrowing of the bowel), fistulas (communications between the bowel and other nearby organs) and abscesses. These are often managed by surgery where bowel is resected and refashioned. Over 50% of people with CD require surgery within 10 years of diagnosis due to complications or disease refractory to medical drugs.
There are many markers to assess severity of inflammation such as cross-sectional imaging, endoscopy, blood and stool tests. These are used to assess response to therapy. Until recently there was no measure of progressive bowel damage. Measurement of bowel damage in CD is complex as the disease affects any part of the gut. Removal of small bowel segments at surgery compromised absorptive capability of the gut contributing to malnutrition, even though the residual bowel is normal. A new score called the Lemann Index was recently validated to capture progressive bowel damage including loss of bowel removed at surgery. This will allow an assessment of the impact of treatment on the natural history of the disease and not just on inflammation.
The objective of the study is to understand and better characterise bowel damage progression in a prospective cohort of newly diagnosis CD patients.
We propose to include patients diagnosed with CD over the last 12 months who are willing to have their data collected to measure the disease progression. The study will be based in 2 NHS hospitals in England and several centres across Europe.
We propose to recruit patients over 2 years and follow them up over 5 years, There will be one additional MRI scan for the purpose of assessing Lemann Index . Patients will undergo routine clinical care and data will be collected for assessment of disease progress.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0035
Date of REC Opinion
15 Feb 2022
REC opinion
Favourable Opinion