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Recruiting NCT05903066

TRansmural hEaliNg Definition in CroHn's Disease (TRENCH 1)

Trial Parameters

Condition Crohn Disease
Sponsor Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Study Type OBSERVATIONAL
Phase N/A
Enrollment 210
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2023-09-28
Completion 2025-07
Interventions
Magnetic Resonance Enterography (MRE)

Brief Summary

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

Eligibility Criteria

Inclusion Criteria: * ≥ 18 years of age * Patient diagnosed with CD for more than 6 months with histological confirmation available in his medical record. * Indication for MRE based on routine clinical practice validated by the treating physician * Any CD treatment will be authorized, such as biologicals (infliximab, adalimumab, vedolizumab, ustekinumab…), or immunomodulators (azathioprine, 6-mercaptopurine, methotrexate…). * The subjects sign and date a written, informed consent form and any required privacy authorization prior to the initiation of the study. * A subject can be enrolled into the study only if the grade of TH (assessed by the LRP) corresponding to the subject is not already fulfilled. Exclusion Criteria: * Pregnancy during the study * People unable to give consent (because of their physical or mental state) * Absence of written consent * Ulcerative colitis or unclassified IBD * Specific postsurgical settings: ileoanal anastomosis, ileostomy or colostomy. * Less than 3

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