Clinical Trials in Spain / NCT05420233
Active, not recruiting
Not applicable
The CROCO Study: CROhn's Disease COhort Study
NCT05420233 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Crohn Disease
Investigational drug(s) / intervention(s)
MRE
MRE: Magnetic Resonance Enterography at year 1 (in some patients)
Study 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.
Eligibility
INCLUSION CRITERIA
To be eligible all of the following criteria must be met:
* Diagnosis of CD (according to ECCO guidelines) established within the past 12 months;
* Patients able to understand the information provided to them and to give written informed consent for the study;
* Male or female, age \> 18 years.
EXCLUSION CRITERIA:
* Patients unwilling or unable to provide informed, written consent;
* Severe underlying medical disorder with an anticipated life expectancy \< 2 years;
* Refusal or medical conditions (e.g. Glomerular filtration rate \< 30 mL/min) preventing cross-sectional imaging during follow-up;
* Uncertain CD diagnosis;
* Pregnancy (if it is impossible to implement the MRE at one year) or any other reason that makes resonance not feasible throughout the study (eg claustrophobia).
Primary outcome measure(s)
- 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. - 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.
Trial sites (19)
| Facility | City | Region | Status |
|---|---|---|---|
| University Hospital CHU of Liège | Liège | Liège | |
| American Gastroenterology Center | Stróvolos | Cyprus | |
| IBD Clinical and Research Clinic, ISCARE | Prague | 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 | |
| Mater dei hospital | Msida | Malta | |
| Hospital Garcia da Orta | Almada | Almada | |
| Instituto Portugues de Oncologia de Lisboa | Lisbon | Lisbon District | |
| Hospital Beatriz Angelo | Loures | Loures | |
| Algomed Policlinic | Timișoara | 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 |
More GLSMED Learning Health S.A. trials in Spain
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05420233 on ClinicalTrials.gov ↗ ← All trials in Spain