Evaluation of Digestive Damage and Associated Predictive Factors in Crohn's Disease 5 to 10 Years After Diagnosis (DESTIN)
研究概览
详细说明
Background: Crohn's disease (CD) is a chronic inflammatory disorder of the bowel that is characterized by periods of clinical remission alternating with periods of recurrence. Persistent inflammation is believed to lead to progressive bowel damage that, over time, will manifest in the development of strictures, fistulae, and abscesses. The recent development of the Lemann index allows us to precisely assess digestive damage in CD. The aim of the present study is to evaluate digestive damage and associated predictive factors in CD 5 to 10 years after diagnosis.
Methods: Prospective, multicenter, international, transversal, observational study. Patients who completed the RAPID trial (evaluating the benefits on the course of CD of an early prescription of azathioprine compared with conventional step-care therapy) will be eligible. Digestive damage will be assessed using methods described in the Lemann index protocol, dependent on CD location (abdominal MRI obligatory). The total duration of study participation for 1patient will be ≤4 months.
Aims: The primary objective is to evaluate digestive damage in CD 5 to 10 years after diagnosis in the GETAID centers included in the RAPID study. Secondary objective is to identify predictive factors of the evolution digestive damage.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Clermont-ferrand、法国、63003
- CHU clermont-ferrand
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Clichy、法国、92110
- Hopital Beaujon
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Lille、法国
- CHRU Lille
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Nice、法国、06202
- CHU NICE
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Paris、法国、75012
- Hôpital Saint-Antoine
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Paris、法国、75010
- Hopital Saint Louis
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Paris、法国、75014
- IMM
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Pessac、法国、33700
- CHU Bordeaux - Pessac
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Toulouse、法国、31403
- CHU Toulouse
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male or female patients over 18 years old
- Active or Inactive Crohn's Disease
- Previously enrolled in RAPID clinical trial
Exclusion Criteria:
- Pregnant or nursing woman
- Patient with a contraindication or who decline to have study exams (MRI and endoscopy)
- Other medical or psychiatric or serious chronic conditions or according to the physician's discretion that could affect the patient's cooperation or the capacity to follow study procedures.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Evaluation group
Digestive damage will be assessed on patients by using the methods described in the Lemann index protocol, dependant of Crohn's disease locations. All patients will have clinical examination and abdominal magnetic resonance imaging analyses. Upper endoscopy, colonoscopy, and pelvic magnetic resonance imaging analyses will be performed according to disease locations :
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Abdominal MRI to realize within 4 months following inclusion
Upper endoscopy to realize within 4 months following inclusion
Colonoscopy to realize within 4 months following inclusion
Pelvic MRI to realize within 4 months following inclusion
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Digestive damage
大体时间：5 to 10 years after diagnosis
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Evaluate digestive damage in Crohn's Disease by using Lemann Index
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5 to 10 years after diagnosis
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Predictive factors of the digestive damage evolution
大体时间：5 to 10 years after diagnosis
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Evaluate digestive damage per organ (upper intestinal tract, small bowel, colon or rectum, anal or perianal) by using Lemann Index
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5 to 10 years after diagnosis
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Predictive factors of the digestive damage evolution
大体时间：5 to 10 years after diagnosis
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Determine correlation between Lemann Index and factors measured at diagnosis and then 5 to 10 years after diagnosis.
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5 to 10 years after diagnosis
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Variation of Lemann Index
大体时间：5 to 10 years after diagnosis
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Variation of Lemann Index 5 to 10 years after diagnosis
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5 to 10 years after diagnosis
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合作者和调查者
调查人员
- 首席研究员：Benjamin Pariente, MD, PhD、Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- 首席研究员：Jacques Cosnes, MD、Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
出版物和有用的链接
一般刊物
- Cosnes J, Bourrier A, Laharie D, Nahon S, Bouhnik Y, Carbonnel F, Allez M, Dupas JL, Reimund JM, Savoye G, Jouet P, Moreau J, Mary JY, Colombel JF; Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Early administration of azathioprine vs conventional management of Crohn's Disease: a randomized controlled trial. Gastroenterology. 2013 Oct;145(4):758-65.e2; quiz e14-5. doi: 10.1053/j.gastro.2013.04.048. Epub 2013 Apr 30.
- Pariente B, Mary JY, Danese S, Chowers Y, De Cruz P, D'Haens G, Loftus EV Jr, Louis E, Panes J, Scholmerich J, Schreiber S, Vecchi M, Branche J, Bruining D, Fiorino G, Herzog M, Kamm MA, Klein A, Lewin M, Meunier P, Ordas I, Strauch U, Tontini GE, Zagdanski AM, Bonifacio C, Rimola J, Nachury M, Leroy C, Sandborn W, Colombel JF, Cosnes J. Development of the Lemann index to assess digestive tract damage in patients with Crohn's disease. Gastroenterology. 2015 Jan;148(1):52-63.e3. doi: 10.1053/j.gastro.2014.09.015. Epub 2014 Sep 21.
有用的网址
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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