Crohn Disease Clinical Trial
Official title:
TRansmural hEaliNg Definition in CroHn's Disease - The TRENCH1 Study
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 : - To analyze intra- and inter-observer variability of radiological findings. - To analyze intra- and inter-observer variability of TH definitions in CD. ;
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