TRansmural hEaliNg Definition in CroHn's Disease (TRENCH 1)
TRENCH 1
1 other identifier
observational
210
2 countries
18
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2023
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedStudy Start
First participant enrolled
September 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedOctober 8, 2024
October 1, 2024
1.8 years
June 5, 2023
October 4, 2024
Conditions
Keywords
Outcome Measures
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.
Day 1
Secondary Outcomes (2)
Intra- and inter-observer variability of lesions observed per segment during MRE in CD
Day 1
Intra- and inter-observer variability of depth and grade of global transmural healing in CD
Day 1
Interventions
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.
Eligibility Criteria
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
You may qualify if:
- ≥ 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
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
APHP - Hôpital Louis Mourier
Colombes, 92700, 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 Nice - Hôpital l'Archet II
Nice, 06200, France
CHU de Nîmes - Hôpital Carémeau
Nîmes, 30029, France
APHP - Hôpital Européen Georges Pompidou (HEGP)
Paris, 75908, France
Hospices Civils de Lyon
Pierre-Bénite, 69475, France
CHU Rennes - Hôpital Pontchaillou
Rennes, 35033, France
CHU de Saint Etienne - Hôpital Nord
Saint-Priest-en-Jarez, 42270, France
CHRU de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, 54500, France
Biospecimen
Blood serum, stool.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sophie GEYL
CHU Limoge Dupuytren
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2023
First Posted
June 15, 2023
Study Start
September 28, 2023
Primary Completion
July 1, 2025
Study Completion
August 1, 2025
Last Updated
October 8, 2024
Record last verified: 2024-10