ClinicalTrials.gg
CompletedNCT05903066TRENCH 1Updated Nov 4, 2026

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. Completed at 13 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

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

Updated Nov 4, 2026Now CompletedPrimary completion moved+4 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
320
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Crohn Disease by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives — 5 open to participants now, 6 under way, none of them phase 3. Crohn Disease · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives.

Started
2023
the only one that year
Observational
6 of 22
3 open now
Registered
16th of 22
by date

Among the 22 studies in Crohn Disease by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives, this one is the only one that started in 2023, is one of 6 observational ones, and was the 16th registered.

By phase

22 studies; the count open now beside each. This study's row is marked.

Phase 49 · 2 open
Observationalthis study6 · 3 open
No phase4 · 0 open
Phase 33 · 0 open

By the year they started

First in 2002; this study’s year is marked. 1 started in 2023.

Size and results

Median enrollment 114 across the 16 interventional studies, 460 across the 6 observational. Of the 15 that completed or were terminated, 0 (0%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 22 studies in Crohn Disease by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives, or all of them as a file.
02

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.
03

Conditions studied

  • Crohn Disease

Browse trials for

Keywords

  • IBD
  • CD
04

Who can participate

The criteria were revised on the registry on Nov 4, 2026. See what changed

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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, 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
  • for MRI
  • Isolated perianal disease without luminal location
  • MRE images of poor quality, based on previously defined criteria
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
320 participants (actual)
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.

06

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

07

Study locations

13 sites
  • CHU de Liège
    Liège, 4000, Belgium
  • CHU Amiens-Picardie (site Sud)
    Amiens, 80054, France
  • CHU de Bordeaux - Hôpital Haut-Lévêque
    Bordeaux, 33600, France
  • APHP - Hôpital Ambroise Paré
    Boulogne-Billancourt, 92100, France
  • CHU de Clermont-Ferrand - Hôpital d'Estaing
    Clermont-Ferrand, 63003, France
  • CHRU de Lille - Hôpital Claude Huriez
    Lille, 59037, France
  • CHU Limoges Dupuytren
    Limoges, 87000, France
  • AP-HM - Hôpital Nord
    Marseille, 13015, France
  • CHU de Montpellier - Hôpital Saint Eloi
    Montpellier, 34295, France
  • CHU de Nantes
    Nantes, 44093, France
  • CHU de Nîmes - Hôpital Carémeau
    Nîmes, 30029, France
  • Hospices Civils de Lyon
    Pierre-Bénite, 69475, France
  • CHU Rennes - Hôpital Pontchaillou
    Rennes, 35033, France
08

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Completed
changed Nov 4, 2026
Sites
5 sites removed
Show 5 removed
  • APHP - Hôpital Louis Mourier · Colombes, France
  • CHU de Nice - Hôpital l'Archet II · Nice, France
  • APHP - Hôpital Européen Georges Pompidou (HEGP) · Paris, France
  • CHU de Saint Etienne - Hôpital Nord · Saint-Priest-en-Jarez, France
  • CHRU de Nancy - Hôpitaux de Brabois · Vandœuvre-lès-Nancy, France
Nov 4, 2026
Primary completion
Jul 2025→Sep 19, 2025 (actual)
Nov 4, 2026
Study completion
Aug 2025→Sep 19, 2025 (actual)
Nov 4, 2026
Enrollment
210 (estimated)→320 (actual)
Nov 4, 2026
Eligibility
1 inclusion criterion edited
What changed in the criteria
Inclusion criteria
  • EditedAny CD treatment will be authorized, such as biologicals (infliximab, adalimumab, vedolizumab, ustekinumab...…), or immunomodulators (azathioprine, 6-mercaptopurine, methotrexate...…).
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Recruiting→Completed
    5 sites removed
    Show 5 removed
    • APHP - Hôpital Louis Mourier · Colombes, France
    • CHU de Nice - Hôpital l'Archet II · Nice, France
    • APHP - Hôpital Européen Georges Pompidou (HEGP) · Paris, France
    • CHU de Saint Etienne - Hôpital Nord · Saint-Priest-en-Jarez, France
    • CHRU de Nancy - Hôpitaux de Brabois · Vandœuvre-lès-Nancy, France
    Primary completion Jul 2025→Sep 19, 2025 (now actual)
    Study completion Aug 2025→Sep 19, 2025 (now actual)
    Enrollment 210 (estimated)→320 (actual)
    Eligibility 1 inclusion criterion edited
    What changed in the criteria
    Inclusion criteria
    • EditedAny CD treatment will be authorized, such as biologicals (infliximab, adalimumab, vedolizumab, ustekinumab...…), or immunomodulators (azathioprine, 6-mercaptopurine, methotrexate...…).
    + 3 other changes: verification date, contact details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

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
Sep 19, 2025
Completion
Sep 19, 2025
Last update
Nov 4, 2026

Study contacts

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 ↗

Not currently enrolling

This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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