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

Crohn Disease Clinical Trial

— TRENCH 1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05903066
• Other study ID #: GETAID-2022-03
• Status: Recruiting
• Start date: October 11, 2023
• Est. completion date: August 2025

Study information

• Verified date: January 2024
• Source: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Contact: Sophie GEYL
• Phone: +33 5 55 05 66 31
• Email: sophie.geyl[@]chu-limoges.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: August 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

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.

Locations

Country	Name	City	State
Belgium	CHU de Liège	Liège
France	CHU Amiens-Picardie (site Sud)	Amiens
France	CHU de Bordeaux - Hôpital Haut-Lévêque	Bordeaux
France	APHP - Hôpital Ambroise Paré	Boulogne-Billancourt
France	CHU de Clermont-Ferrand - Hôpital d'Estaing	Clermont-Ferrand
France	APHP - Hôpital Louis Mourier	Colombes
France	CHRU de Lille - Hôpital Claude Huriez	Lille
France	CHU Limoges Dupuytren	Limoges
France	AP-HM - Hôpital Nord	Marseille
France	CHU de Montpellier - Hôpital Saint Eloi	Montpellier
France	CHU de Nantes	Nantes
France	CHU de Nice - Hôpital l'Archet II	Nice
France	CHU de Nîmes - Hôpital Carémeau	Nîmes
France	APHP - Hôpital Européen Georges Pompidou (HEGP)	Paris
France	Hospices Civils de Lyon	Pierre-Bénite
France	CHU Rennes - Hôpital Pontchaillou	Rennes
France	CHU de Saint Etienne - Hôpital Nord	Saint-Priest-en-Jarez
France	CHRU de Nancy - Hôpitaux de Brabois	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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