Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Diseases (MicroMICI)
Evaluation of the Diagnostic Value of microRNAs for Inflammatory Bowel Disease
調査の概要
詳細な説明
RATIONAL Inflammatory Bowel Disease (IBD) affects more than 200,000 people in France and 1.5 million in Europe. Difficulties in the management of IBD are related to the need for invasive tests for the diagnosis of IBD (endoscopy), partly explaining the delay in diagnosis, and the inability to distinguish early colonic Crohn's disease of ulcerative colitis (UC) in 10-30% of cases.
Recently, we identified real-time polymerase chain reaction (PCR), from healthy colonic mucosa of IBD patients, a molecular signature of IBD involving 10 microRNA (miRNA) Common (miR26a, miR29a, miR29b, miR126 * miR15a, miR127-3p, miR324 -3p, miR30c, miR185, miR196a) and 15 colic chronic disease (MC) and ulcerative colitis (RCH) discriminating microRNA (miR-142-3p, miR-142-5p, miR-146a, miR-146b-5p, miR150, miR-181d, miR-182, miR199a -3p, miR199a-5p, miR199b-5p, miR-203, miR223, miR-299-5p, miR320a, miR-328).
TYPE OF STUDY : multicenter diagnostic evaluation Study
MAIN PURPOSE OF THE STUDY : To evaluate the diagnostic value of microRNA in colonic IBD (ulcerative colitis or Crohn's disease) in adults as compared to healthy controls (and non-IBD colitis)
SECONDARY OBJECTIVES :
- assess the ability of microRNA to discriminate a colic chronic disease (MC) of ulcerative colitis (RCH) in adults
- evaluate the diagnostic value of microRNA in inflammatory colitis child
- explore the possibility of measuring miRNA of interest in the stool
PRODUCTS OF THE STUDY diagnostic kit of IBD in quantitative polymerase chain reaction (qPCR)
NUMBER OF PATIENTS : 6 groups of 50 patients each will be included
- Group 1: Crohn adult colic
- Group 2: ulcerative colitis (RCH) adults
- Group 3: Witnesses healthy adults
- Group 4: Witnesses adults with non-IBD inflammation
- Group 5: Children with colitis
- Group 6 : Witnesses healthy children
INCLUSION LENGTH 30 months
DURATION OF THE STUDY 30 months
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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Clichy、フランス、92110
- Hopital Beaujon
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Paris、フランス、75010
- Hôpital Saint louis
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Paris、フランス、75015
- Hôpital Necker Enfants Malades
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Paris、フランス、75012
- Hopital Saint Antoine
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Paris、フランス、75019
- Hôpital Robert Deré
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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 :
- Target Population : Patients (children and adults), man or woman, suffering from Crohn's disease with colonic involvement or ulcerative colitis according to the criteria of the European consensus (ECCO 2010)
- Control population: healthy subjects and any non-Crohn's colitis or ulcerative colitis
- Having a colonoscopy examination indication,
- Who signed the consent form (for adults and signed parental consent obtained for patients minors)
Exclusion Criteria:
- No health insurance ,
- mental disability,
- pregnancy
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:診断
- 割り当て:非ランダム化
- 介入モデル:並列代入
- 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 |
---|---|
他の:Crohn adult colic
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
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testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
他の:RCH adults
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
他の:Witnesses healthy adults
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
他の:Witnesses adults with non-IBD inflammation
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
他の:Children with colitis
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
他の:Witnesses healthy children
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
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 |
---|---|---|
Evaluate the diagnostic value of microRNAs in qPCR,in IBD colon (ulcerative colitis or Crohn's disease) in adults compared to health
時間枠:1 day
|
Evaluate the diagnostic value of microRNAs in qPCR, suitable for routine use, initially testing the expression of 25 miRNAs from endoscopic biopsies in IBD colon (ulcerative colitis or Crohn's disease) in adults compared to health
|
1 day
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
- Evaluate the ability of miRNAs to discriminate a MC colic of UC in adults
時間枠:1 day
|
1 day
|
Evaluate the diagnostic value of microRNAs in inflammatory colitis child
時間枠:1 day
|
1 day
|
- Study the possibility of measuring miRNA of interest in feces and saliva
時間枠:1 day
|
1 day
|
協力者と研究者
捜査官
- 主任研究者:Xavier Treton, MD,PhD、Assistance Publique - Hôpitaux de Paris
研究記録日
主要日程の研究
研究開始
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
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