The CROCO Study: CROhn's Disease COhort Study
- Conditions
- Crohn Disease
- Interventions
- Diagnostic Test: MRE
- Registration Number
- NCT05420233
- Lead Sponsor
- GLSMED Learning Health S.A.
- Brief Summary
The investigators propose to create a prospective Crohn Disease cohort, where patients receiving the most up-to-date therapies with a treat-to-target strategy, will be closely followed to characterize the progression of Crohn Disease by measuring the Lémann Index over time. The goal of the CROCO Study - "Crohn's Disease Cohort Study" is to promote a greater understanding of the long-term evolution of Crohn Disease , to describe prospectively the impact of different therapeutic strategies and develop accurate predictors of bowel disease damage and disability.
- Detailed Description
Therefore, the investigators designed a prospective, multicentre, study of the clinical course, anatomical progression and treatment of newly diagnosed CD and plan to include 600 patients over a 2-year period. Patients will be followed over 5 years after diagnosis (the date of diagnosis will be the date of the index histopathology describing CD; in special situations where pathology is not available the date of diagnosis will be the date that CD was declared by the physician). A morphological evaluation (LI), using abdominal magnetic resonance, will be performed at 1, 3 and 5 years after diagnosis. Ileocolonoscopy, upper endoscopy and/or pelvic MRI will be included according to disease location. Patients will be treated with standard of care therapy and will be followed for 5 years after diagnosis, with semestrial visits after the Year 1 (LI 1). At each visit, clinical and laboratory markers will be collected. Perianal and abdominal surgeries during follow-up will be registered. The disability index questionnaire will also be recorded every year.
A preliminary requisite is therefore to implement and standardize examination reports and damage definitions used to calculate the LI. To this end, training session, supervised by members of the steering committee, will be held for participating gastroenterologist and radiologists. Based on commented ileocolonoscopy, upper endoscopy abdominal MRI and pelvic MRI, these sessions will highlight how lesions should be characterized and graded accordingly to implement the Lémann Index.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients diagnosed with Crohn´s disease within the past 12 months MRE All patients will undergo MRE in year 1, and this test may not be recommended in all patients. Year 1 MRE is the only procedure that may be performed outside of clinical practice.
- Primary Outcome Measures
Name Time Method Lémann Index Y3 3 years after diagnosis The Lémann Index (LI) was developed to provide a tool to measure bowel damage in Crohn Disease (CD).
Descriptive statistics will present quantitative variables as mean and standard deviation or median and interquartile range (depending on their distribution) and qualitative variables as count and percentage.
Time to event endpoints (such as surgery and hospitalization) will be presented using cumulative incidence in a competing risk framework (with death without surgery as a competing event for time to surgery, for example). Cumulative incidence with its 95%CI will be estimated at meaningful timepoints and association between baseline predictors and time to event endpoint will be assessed using competing risks regression models. Correlation of LI and IBD-DI will be estimated, taking into account the repeated measurements.
Lémann Index is a continuous variable.Lémann Index Y5 5 years after diagnosis The Lémann Index (LI) was developed to provide a tool to measure bowel damage in Crohn Disease (CD).
Descriptive statistics will present quantitative variables as mean and standard deviation or median and interquartile range (depending on their distribution) and qualitative variables as count and percentage.
Time to event endpoints (such as surgery and hospitalization) will be presented using cumulative incidence in a competing risk framework (with death without surgery as a competing event for time to surgery, for example). Cumulative incidence with its 95%CI will be estimated at meaningful timepoints and association between baseline predictors and time to event endpoint will be assessed using competing risks regression models. Correlation of LI and IBD-DI will be estimated, taking into account the repeated measurements.
Lémann Index is a continuous variable.Lémann Index Y1 1 year after diagnosis The Lémann Index (LI) was developed to provide a tool to measure bowel damage in Crohn Disease (CD).
Descriptive statistics will present quantitative variables as mean and standard deviation or median and interquartile range (depending on their distribution) and qualitative variables as count and percentage.
Time to event endpoints (such as surgery and hospitalization) will be presented using cumulative incidence in a competing risk framework (with death without surgery as a competing event for time to surgery, for example). Cumulative incidence with its 95%CI will be estimated at meaningful timepoints and association between baseline predictors and time to event endpoint will be assessed using competing risks regression models. Correlation of LI and IBD-DI will be estimated, taking into account the repeated measurements.
Lémann Index is a continuous variable.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
University Hospital CHU of Liège
🇧🇪Liège, Belgium
American Gastroenterology Center
🇨🇾Stróvolos, Cyprus
IBD Clinical and Research Clinic, ISCARE
🇨🇿Praha, Czechia
Hvidovre Hospital
🇩🇰Hvidovre, Denmark
Slagelse Hospital
🇩🇰Slagelse, Denmark
CHU Amiens-Picardie Hôpital Sud
🇫🇷Amiens, France
CHU Estaing Clermont - Ferrand
🇫🇷Clermont-Ferrand, France
Claude Huriez Hospital, Lille University
🇫🇷Lille, France
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
Ospedale San Raffaele
🇮🇹San Raffaele, Italy
Mater dei hospital
🇲🇹Imsida, Malta
Hospital Garcia da Orta
🇵🇹Almada, Portugal
Instituto Portugues de Oncologia de Lisboa
🇵🇹Lisboa, Portugal
Hospital Beatriz Angelo
🇵🇹Loures, Portugal
Algomed Policlinic
🇷🇴Timişoara, Romania
Hospital Clinic Barcelona
🇪🇸Barcelona, Spain
Hospital Galdakao-Usansolo
🇪🇸Galdakao, Spain
Hospital Alvaro Cunqueiro - Área Sanitária de Vigo
🇪🇸Vigo, Spain
Hull University Teaching Hospitals NHS Trust
🇬🇧Hull, United Kingdom
St Mark's Hospital
🇬🇧London, United Kingdom