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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-28

Study Completion Date

2025-08-31

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

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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.

Conditions

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Crohn Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No