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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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TRansmural hEaliNg Definition in CroHn's Disease - The TRENCH1 Study

Conditions
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Crohn Disease

Intervention / Treatment
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* Procedure: Magnetic Resonance Enterography (MRE)


Participation Criteria
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Eligibility Criteria
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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 evaluable ileocolic segments or more than 3 resected ileocolonic segments (not counting ileocecal valve) Severe obstructive symptoms Symptomatic intra-abdominal abscess Contraindication for MRI Isolated perianal disease without luminal location MRE images of poor quality, based on previously defined criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Magnetic Resonance Enterography (MRE)|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBD, CD