The CROCO (CROhn's Disease COhort Study) - study design and protocol

Area of Science:

• Gastroenterology
• Inflammatory Bowel Disease Research
• Clinical Trial Methodology

Background:

• Crohn's disease (CD) is a chronic inflammatory condition causing significant bowel damage and disability.
• The Lémann Index (LI) measures cumulative bowel damage in CD, assessing stricturing, penetrating, and surgical lesions.
• Limited prospective data exists on bowel damage progression in newly diagnosed CD patients.

Purpose of the Study:

• To characterize bowel damage progression using the LI in recently diagnosed CD patients over five years.
• To assess the relationship between bowel damage progression and disease features like phenotype, treatments, biomarkers, and disability.
• To establish predictors of bowel damage progression and its link to disability.

Main Methods:

• The Crohn's Disease Cohort Study (CROCO Study) is a prospective, multicentre European cohort.
• Patients with CD diagnosed within 12 months are followed for 5 years, receiving standard care.
• The LI and disability (IBD-DI) are assessed at intervals; the primary outcome is the absolute LI at year 3.

Main Results:

• This section is not yet available as the study is ongoing.
• Data collection and analysis are in progress to evaluate longitudinal changes in bowel damage.
• The study aims to identify key factors influencing CD progression.

Conclusions:

• The CROCO Study provides a unique dataset for understanding CD natural history and evolution.
• Findings will aid in developing predictive scores for bowel damage progression.
• This research will support the design of future clinical trials for CD therapies.