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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A00310-45 | Other Identifier | IDRCB |
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The purpose of this study is to assess the diagnostic value of microRNAs in IBD colon (ulcerative colitis or Crohn's disease) in adults as compared to healthy controls (and non-IBD colitis)
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 :
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
INCLUSION LENGTH 30 months
DURATION OF THE STUDY 30 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crohn adult colic | Other | testing qPCR diagnostic KIT of microRNAS from colonic biopsies |
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| RCH adults | Other | testing qPCR diagnostic KIT of microRNAS from colonic biopsies |
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| Witnesses healthy adults | Other | testing qPCR diagnostic KIT of microRNAS from colonic biopsies |
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| Witnesses adults with non-IBD inflammation | Other | testing qPCR diagnostic KIT of microRNAS from colonic biopsies |
|
| Children with colitis | Other | testing qPCR diagnostic KIT of microRNAS from colonic biopsies |
|
| Witnesses healthy children | Other |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| qPCR diagnostic KIT of microRNAS | Device | testing qPCR diagnostic KIT of microRNAS from colonic biopsies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the diagnostic value of microRNAs in qPCR,in IBD colon (ulcerative colitis or Crohn's disease) in adults compared to health | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| - Evaluate the ability of miRNAs to discriminate a MC colic of UC in adults | 1 day | |
| Evaluate the diagnostic value of microRNAs in inflammatory colitis child | 1 day | |
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Inclusion criteria :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier Treton, MD,PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Beaujon | Clichy | 92110 | France | |||
| Hôpital Saint Louis |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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testing qPCR diagnostic KIT of microRNAS from colonic biopsies
|
| - Study the possibility of measuring miRNA of interest in feces and saliva |
| 1 day |
| Paris |
| 75010 |
| France |
| Hôpital Saint Antoine | Paris | 75012 | France |
| Hôpital Necker Enfants Malades | Paris | 75015 | France |
| Hôpital Robert Deré | Paris | 75019 | France |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |