TRansmural hEaliNg Definition in CroHn's Disease - The TRENCH1 Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 18
- 主要终点
- Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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.
排除标准
- •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
结局指标
主要结局
Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD
时间窗: Day 1
An index (depth of remission) or score (grade of remission) will be constructed through multiple linear or logistic mixed regression models.
次要结局
- Intra- and inter-observer variability of depth and grade of global transmural healing in CD(Day 1)
- Intra- and inter-observer variability of lesions observed per segment during MRE in CD(Day 1)