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RecruitingNCT05903066TRENCH 1Updated Oct 8, 2024

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

An observational study in Crohn Disease, sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives. Recruiting at 18 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-08.

Sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
210
Ages
18 Years to 75 Years
Sex
All
01

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

Read the 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.
02

Conditions studied

  • Crohn Disease

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Keywords

  • IBD
  • CD
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with CD for more than 6 months with histological confirmation available in his medical record, with an indication for MRE based on routine clinical practice validated by the treating physician

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
210 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • ProcedureMagnetic 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1

Secondary outcomes

  1. 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.

    Time frame: Day 1

  2. 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.

    Time frame: Day 1

06

Study locations

4 of 18 sites recruiting
  • CHU de Liège
    Liège, 4000, Belgium
    Not yet recruiting
  • CHU Amiens-Picardie (site Sud)
    Amiens, 80054, France
    Recruiting
  • CHU de Bordeaux - Hôpital Haut-Lévêque
    Bordeaux, 33600, France
    Not yet recruiting
  • APHP - Hôpital Ambroise Paré
    Boulogne-Billancourt, 92100, France
    Not yet recruiting
  • CHU de Clermont-Ferrand - Hôpital d'Estaing
    Clermont-Ferrand, 63003, France
    Recruiting
  • APHP - Hôpital Louis Mourier
    Colombes, 92700, France
    Not yet recruiting
  • CHRU de Lille - Hôpital Claude Huriez
    Lille, 59037, France
    Not yet recruiting
  • CHU Limoges Dupuytren
    Limoges, 87000, France
    Recruiting
  • AP-HM - Hôpital Nord
    Marseille, 13015, France
    Not yet recruiting
  • CHU de Montpellier - Hôpital Saint Eloi
    Montpellier, 34295, France
    Recruiting
  • CHU de Nantes
    Nantes, 44093, France
    Not yet recruiting
  • CHU de Nice - Hôpital l'Archet II
    Nice, 06200, France
    Not yet recruiting
  • CHU de Nîmes - Hôpital Carémeau
    Nîmes, 30029, France
    Not yet recruiting
  • APHP - Hôpital Européen Georges Pompidou (HEGP)
    Paris, 75908, France
    Not yet recruiting
  • Hospices Civils de Lyon
    Pierre-Bénite, 69475, France
    Not yet recruiting
  • CHU Rennes - Hôpital Pontchaillou
    Rennes, 35033, France
    Not yet recruiting
  • CHU de Saint Etienne - Hôpital Nord
    Saint-Priest-en-Jarez, 42270, France
    Not yet recruiting
  • CHRU de Nancy - Hôpitaux de Brabois
    Vandœuvre-lès-Nancy, 54500, France
    Not yet recruiting
07

Registry details

Key details

Study ID
NCT05903066
Lead sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Responsible party
Sponsor
First posted
Jun 15, 2023
Start date
Sep 28, 2023
Primary completion
Jul 2025 (estimated)
Completion
Aug 2025 (estimated)
Last update
Oct 8, 2024

Study contacts

Sophie GEYL
Contact
sophie.geyl@chu-limoges.fr
+33 5 55 05 66 31
Laurent PEYRIN-BIROULET
Contact
peyrinbiroulet@gmail.com
+33 3 83 15 36 61
Sophie GEYL
principal investigator · CHU Limoge Dupuytren

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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