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

Last updated: October 4, 2024
Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Magnetic Resonance Enterography (MRE)

Clinical Study ID

NCT05903066
GETAID-2022-03
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥ 18 years of age

  • Patient diagnosed with CD for more than 6 months with histological confirmationavailable in his medical record.

  • Indication for MRE based on routine clinical practice validated by the treatingphysician

  • 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 privacyauthorization prior to the initiation of the study.

  • A subject can be enrolled into the study only if the grade of TH (assessed by theLRP) corresponding to the subject is not already fulfilled.

Exclusion

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 ileocolonicsegments (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

Study Design

Total Participants: 210
Treatment Group(s): 1
Primary Treatment: Magnetic Resonance Enterography (MRE)
Phase:
Study Start date:
September 28, 2023
Estimated Completion Date:
August 31, 2025

Study 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.

Connect with a study center

  • CHU de Liège

    Liège, 4000
    Belgium

    Site Not Available

  • CHU Amiens-Picardie (site Sud)

    Amiens, 80054
    France

    Active - Recruiting

  • CHU de Bordeaux - Hôpital Haut-Lévêque

    Bordeaux, 33600
    France

    Site Not Available

  • APHP - Hôpital Ambroise Paré

    Boulogne-Billancourt, 92100
    France

    Site Not Available

  • CHU de Clermont-Ferrand - Hôpital d'Estaing

    Clermont-Ferrand, 63003
    France

    Active - Recruiting

  • APHP - Hôpital Louis Mourier

    Colombes, 92700
    France

    Site Not Available

  • CHRU de Lille - Hôpital Claude Huriez

    Lille, 59037
    France

    Site Not Available

  • CHU Limoges Dupuytren

    Limoges, 87000
    France

    Active - Recruiting

  • AP-HM - Hôpital Nord

    Marseille, 13015
    France

    Site Not Available

  • CHU de Montpellier - Hôpital Saint Eloi

    Montpellier, 34295
    France

    Active - Recruiting

  • CHU de Nantes

    Nantes, 44093
    France

    Site Not Available

  • CHU de Nice - Hôpital l'Archet II

    Nice, 06200
    France

    Site Not Available

  • CHU de Nîmes - Hôpital Carémeau

    Nîmes, 30029
    France

    Site Not Available

  • APHP - Hôpital Européen Georges Pompidou (HEGP)

    Paris, 75908
    France

    Site Not Available

  • Hospices Civils de Lyon

    Pierre-Bénite, 69475
    France

    Site Not Available

  • CHU Rennes - Hôpital Pontchaillou

    Rennes, 35033
    France

    Site Not Available

  • CHU de Saint Etienne - Hôpital Nord

    Saint-Priest-en-Jarez, 42270
    France

    Site Not Available

  • CHRU de Nancy - Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, 54500
    France

    Site Not Available

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