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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура Magnetic 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.

Первичные конечные точки

• Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD [Срок оценки: Day 1]

Вторичные конечные точки (2)

• Intra- and inter-observer variability of lesions observed per segment during MRE in CD [Срок оценки: Day 1]
• Intra- and inter-observer variability of depth and grade of global transmural healing in CD [Срок оценки: Day 1]

Критерии участия

Критерии включения

• ≥ 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 17 центров

• CHU Amiens-Picardie (site Sud) — Amiens
• CHU de Bordeaux - Hôpital Haut-Lévêque — Bordeaux
• APHP - Hôpital Ambroise Paré — Boulogne-Billancourt
• CHU de Clermont-Ferrand - Hôpital d'Estaing — Clermont-Ferrand
• APHP - Hôpital Louis Mourier — Colombes
• CHRU de Lille - Hôpital Claude Huriez — Lille
• CHU Limoges Dupuytren — Limoges
• AP-HM - Hôpital Nord — Marseille
• … и ещё 9 центров

Бельгия · 1 центр

• CHU de Liège — Liège

Идентификаторы

NCT: NCT05903066 · GETAID-2022-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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