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

Official title

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

Overview

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

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.

Interventions

• 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.

Primary outcome measures

• Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD [Time frame: Day 1]

Secondary outcome measures (2)

• Intra- and inter-observer variability of lesions observed per segment during MRE in CD [Time frame: Day 1]
• Intra- and inter-observer variability of depth and grade of global transmural healing in CD [Time frame: Day 1]

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 17 centers

• CHU Amiens-Picardie (site Sud) — Amiens
• CHU de Bordeaux - Hôpital Haut-Lévêque — Bordeaux
• APHP - Hôpital Ambroise Paré — Boulogne-Billancourt
• CHU de Clermont-Ferrand - Hôpital d'Estaing — Clermont-Ferrand
• APHP - Hôpital Louis Mourier — Colombes
• CHRU de Lille - Hôpital Claude Huriez — Lille
• CHU Limoges Dupuytren — Limoges
• AP-HM - Hôpital Nord — Marseille
• … and 9 more centers

Belgium · 1 center

• CHU de Liège — Liège

Identifiers

NCT: NCT05903066 · GETAID-2022-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗