TRansmural hEaliNg Definition in CroHn's Disease (TRENCH 1)
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 :
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To analyze intra- and inter-observer variability of radiological findings.
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To analyze intra- and inter-observer variability of TH definitions in CD.
Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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≥ 18 years of age
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Patient diagnosed with CD for more than 6 months with histological confirmation available in his medical record.
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Indication for MRE based on routine clinical practice validated by the treating physician
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Any CD treatment will be authorized, such as biologicals (infliximab, adalimumab, vedolizumab, ustekinumab…), or immunomodulators (azathioprine, 6-mercaptopurine, methotrexate…).
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The subjects sign and date a written, informed consent form and any required privacy authorization prior to the initiation of the study.
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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:
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Pregnancy during the study
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People unable to give consent (because of their physical or mental state)
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Absence of written consent
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Ulcerative colitis or unclassified IBD
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Specific postsurgical settings: ileoanal anastomosis, ileostomy or colostomy.
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Less than 3 evaluable ileocolic segments or more than 3 resected ileocolonic segments (not counting ileocecal valve)
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Severe obstructive symptoms
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Symptomatic intra-abdominal abscess
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Contraindication for MRI
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Isolated perianal disease without luminal location
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MRE images of poor quality, based on previously defined criteria
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Liège | Liège | Belgium | 4000 | |
| 2 | CHU Amiens-Picardie (site Sud) | Amiens | France | 80054 | |
| 3 | CHU de Bordeaux - Hôpital Haut-Lévêque | Bordeaux | France | 33600 | |
| 4 | APHP - Hôpital Ambroise Paré | Boulogne-Billancourt | France | 92100 | |
| 5 | CHU de Clermont-Ferrand - Hôpital d'Estaing | Clermont-Ferrand | France | 63003 | |
| 6 | APHP - Hôpital Louis Mourier | Colombes | France | 92700 | |
| 7 | CHRU de Lille - Hôpital Claude Huriez | Lille | France | 59037 | |
| 8 | CHU Limoges Dupuytren | Limoges | France | 87000 | |
| 9 | AP-HM - Hôpital Nord | Marseille | France | 13015 | |
| 10 | CHU de Montpellier - Hôpital Saint Eloi | Montpellier | France | 34295 | |
| 11 | CHU de Nantes | Nantes | France | 44093 | |
| 12 | CHU de Nice - Hôpital l'Archet II | Nice | France | 06200 | |
| 13 | CHU de Nîmes - Hôpital Carémeau | Nîmes | France | 30029 | |
| 14 | APHP - Hôpital Européen Georges Pompidou (HEGP) | Paris | France | 75908 | |
| 15 | Hospices Civils de Lyon | Pierre-Bénite | France | 69475 | |
| 16 | CHU Rennes - Hôpital Pontchaillou | Rennes | France | 35033 | |
| 17 | CHU de Saint Etienne - Hôpital Nord | Saint-Priest-en-Jarez | France | 42270 | |
| 18 | CHRU de Nancy - Hôpitaux de Brabois | Vandœuvre-lès-Nancy | France | 54500 |
Sponsors and Collaborators
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Investigators
- Principal Investigator: Sophie GEYL, CHU Limoge Dupuytren
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GETAID-2022-03