Evaluation of Digestive Damage and Associated Predictive Factors in Crohn's Disease 5 to 10 Years After Diagnosis (DESTIN)
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
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Clermont-ferrand、フランス、63003
- CHU clermont-ferrand
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Clichy、フランス、92110
- Hopital Beaujon
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Lille、フランス
- CHRU Lille
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Nice、フランス、06202
- CHU NICE
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Paris、フランス、75012
- Hôpital Saint-Antoine
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Paris、フランス、75010
- Hopital Saint Louis
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Paris、フランス、75014
- IMM
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Pessac、フランス、33700
- CHU Bordeaux - Pessac
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Toulouse、フランス、31403
- CHU Toulouse
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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 :
|
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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Digestive damage
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Predictive factors of the digestive damage evolution
時間枠：5 to 10 years after diagnosis
|
Evaluate digestive damage per organ (upper intestinal tract, small bowel, colon or rectum, anal or perianal) by using Lemann Index
|
5 to 10 years after diagnosis
|
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Predictive factors of the digestive damage evolution
時間枠：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
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Benjamin Pariente, MD, PhD、Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- 主任研究者：Jacques Cosnes, MD、Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
出版物と役立つリンク
一般刊行物
- 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.
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2015-4
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