About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

MRE
Diagnostic test
Magnetic Resonance Enterography at year 1 (in some patients)

Treatment groups

600 Participants

are divided into 1 treatment group

Group A: Patients diagnosed with Crohn´s disease within the past 12 monthsOther 1 intervention

Trial outcomes

Primary outcomes

1

Lémann Index Y1

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.

Time frame

1 year after diagnosis

2

Lémann Index Y3

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.

Time frame

3 years after diagnosis

3

Lémann Index Y5

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.

Time frame

5 years after diagnosis

The CROCO Study: CROhn's Disease COhort Study

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts