TRansmural hEaliNg Definition in CroHn's Disease (TRENCH 1)
- Conditions
- Crohn Disease
- Registration Number
- NCT05903066
- Lead Sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- 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
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 210
- ≥ 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD Day 1 An index (depth of remission) or score (grade of remission) will be constructed through multiple linear or logistic mixed regression models.
- Secondary Outcome Measures
Name Time Method Intra- and inter-observer variability of depth and grade of global transmural healing in CD 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.
Intra- and inter-observer variability of lesions observed per segment during MRE in CD 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.
Trial Locations
- Locations (18)
CHU de Liège
🇧🇪Liège, Belgium
APHP - Hôpital Louis Mourier
🇫🇷Colombes, France
AP-HM - Hôpital Nord
🇫🇷Marseille, France
CHU de Nîmes - Hôpital Carémeau
🇫🇷Nîmes, France
Hospices Civils de Lyon
🇫🇷Pierre-Bénite, France
APHP - Hôpital Ambroise Paré
🇫🇷Boulogne-Billancourt, France
CHU Amiens-Picardie (site Sud)
🇫🇷Amiens, France
CHU de Bordeaux - Hôpital Haut-Lévêque
🇫🇷Bordeaux, France
CHU de Clermont-Ferrand - Hôpital d'Estaing
🇫🇷Clermont-Ferrand, France
CHRU de Lille - Hôpital Claude Huriez
🇫🇷Lille, France
CHU Limoges Dupuytren
🇫🇷Limoges, France
CHU de Montpellier - Hôpital Saint Eloi
🇫🇷Montpellier, France
CHU de Nantes
🇫🇷Nantes, France
CHU de Nice - Hôpital l'Archet II
🇫🇷Nice, France
APHP - Hôpital Européen Georges Pompidou (HEGP)
🇫🇷Paris, France
CHU Rennes - Hôpital Pontchaillou
🇫🇷Rennes, France
CHU de Saint Etienne - Hôpital Nord
🇫🇷Saint-Priest-en-Jarez, France
CHRU de Nancy - Hôpitaux de Brabois
🇫🇷Vandœuvre-lès-Nancy, France