An observational study in Crohn Disease, sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives. Recruiting at 18 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Observational
Multicenter prospective cross-sectional study of CD patients, its aim is the construction of an objective and reproducible system for evaluation of Transmural healing in Crohn's Disease (CD).
Primary objective : Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD
Number of patients : 210 patients, in 14 sites (only one investigator per site), 15 patients per site, 5 patients per grade of transmural healing based on the appraisal of a local reader pair (a gastroenterologist and a radiologist).
Recruitment period : 2 years
Primary Endpoint : Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD
Secondary Endpoints :
Patients diagnosed with CD for more than 6 months with histological confirmation available in his medical record, with an indication for MRE based on routine clinical practice validated by the treating physician
Exclusion Criteria:
MRE performed as part of the standard of care follow up of the patient, the exam will be recorded for the study and analysed by central readers.
Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD
An index (depth of remission) or score (grade of remission) will be constructed through multiple linear or logistic mixed regression models.
Time frame: Day 1
Intra- and inter-observer variability of lesions observed per segment during MRE in CD
Variations in MRE readings images between the CR will be quantified through the Kappa coefficient for qualitative items and through the intraclass correlation coefficient for quantitative items.
Time frame: Day 1
Intra- and inter-observer variability of depth and grade of global transmural healing in CD
Variations in MRE readings images between the CR will be quantified through the Kappa coefficient for qualitative items and through the intraclass correlation coefficient for quantitative items.
Time frame: Day 1
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Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives