NCT05903066

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 210 (estimated)
• Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-28
• Primary completion: 2025-07-01
• Completion: 2025-08-01
• First posted: 2023-06-15
• Last updated: 2024-10-08

Locations

18 sites across 2 countries: Belgium, France