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

October 4, 2024 updated by: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Liège, Belgium, 4000
  • France
      • Amiens, France, 80054
        • Recruiting
        • CHU Amiens-Picardie (site Sud)
        • Contact:
        • Principal Investigator:
          • Mathurin FUMERY
      • Bordeaux, France, 33600
        • Not yet recruiting
        • Chu de Bordeaux - Hopital Haut-Leveque
        • Principal Investigator:
          • David Laharie
        • Contact:
      • Boulogne-Billancourt, France, 92100
        • Not yet recruiting
        • APHP - Hôpital Ambroise Paré
        • Contact:
        • Principal Investigator:
          • Thomas Bazin
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU de Clermont-Ferrand - Hopital d'Estaing
        • Principal Investigator:
          • Anthony Buisson
        • Contact:
      • Colombes, France, 92700
        • Not yet recruiting
        • APHP - Hôpital Louis Mourier
        • Contact:
        • Principal Investigator:
          • Benoît Coffin
      • Lille, France, 59037
        • Not yet recruiting
        • CHRU de Lille - Hopital Claude Huriez
        • Contact:
        • Principal Investigator:
          • Sofia Hambli
      • Limoges, France, 87000
      • Marseille, France, 13015
        • Not yet recruiting
        • AP-HM - Hôpital Nord
        • Contact:
        • Principal Investigator:
          • Melanie Serrero
      • Montpellier, France, 34295
        • Recruiting
        • CHU De Montpellier - Hopital Saint Eloi
        • Principal Investigator:
          • Romain ALTWEGG
        • Contact:
      • Nantes, France, 44093
        • Not yet recruiting
        • CHU de Nantes
        • Principal Investigator:
          • Catherine Le Berre
        • Contact:
      • Nice, France, 06200
        • Not yet recruiting
        • CHU de Nice - Hôpital l'Archet II
        • Contact:
        • Principal Investigator:
          • Xavier Hebuterne
      • Nîmes, France, 30029
        • Not yet recruiting
        • CHU de Nîmes - Hôpital Carémeau
        • Contact:
        • Principal Investigator:
          • Ludovic Caillo
      • Paris, France, 75908
        • Not yet recruiting
        • APHP - Hôpital Européen Georges Pompidou (HEGP)
        • Contact:
        • Principal Investigator:
          • Mathilde Wisniewski
      • Pierre-Bénite, France, 69475
        • Not yet recruiting
        • Hospices Civils de Lyon
        • Principal Investigator:
          • Stéphane NANCEY
        • Contact:
      • Rennes, France, 35033
        • Not yet recruiting
        • CHU Rennes - Hôpital Pontchaillou
        • Principal Investigator:
          • Guillaume Bouguen
        • Contact:
      • Saint-Priest-en-Jarez, France, 42270
        • Not yet recruiting
        • CHU de Saint Etienne - Hopital Nord
        • Contact:
        • Principal Investigator:
          • Xavier Roblin
      • Vandœuvre-lès-Nancy, France, 54500
        • Not yet recruiting
        • CHRU de Nancy - Hopitaux de Brabois
        • Principal Investigator:
          • Laurent Peyrin-Biroulet
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD
Time Frame: Day 1
An index (depth of remission) or score (grade of remission) will be constructed through multiple linear or logistic mixed regression models.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra- and inter-observer variability of lesions observed per segment during MRE in CD
Time Frame: Day 1
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
Intra- and inter-observer variability of depth and grade of global transmural healing in CD
Time Frame: Day 1
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Investigators

  • Principal Investigator: Sophie GEYL, CHU Limoge Dupuytren

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2023

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

June 5, 2023

First Submitted That Met QC Criteria

June 5, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 4, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GETAID-2022-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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