i-BANK: IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE
Study Details
Study Description
Brief Summary
Interventional study of a group of patients with an inflammatory bowel disease (Crohn's disease or ulcerative colitis) to identify predictive and prognostic biomarkers of natural history and response to biotherapies.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Percentage of primary responders who haven't lost response to biotherapies during follow-up (anti-TNF, ustekinumab, vedolizumab).
Response to treatment will be evaluated using objective criteria for measuring intestinal inflammation: endoscopic remission (endoscopic biopsy and surgical specimens), radiological (MRI), and / or biological (CRP, fecal calprotectin) .
Response to therapy rates will be correlated with genomic, epigenomic, and microbiota data stratified by major environmental factors (nutrition, tobacco, physical activity).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: IBD patients All patients with an established Crohn's disease or ulcerative colitis |
Procedure: endoscopic biopsy
Per-endoscopic biopsies
Procedure: samples of the oral cavity
7 samples of the oral cavity with a swab
Procedure: Samples of the resected specimen
if patient has to undergo a digestive resection as part of his standard management, samples of the pathological area and samples at the end of the resection will be realised
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab). [5 years]
Secondary Outcome Measures
- Proportion of patients who underwent surgery [5 years]
- Post-operative morbidity rates in IBD [5 years]
- Surgical recurrent rate in Crohn's disease [5 years]
- Propotion of patients with a destruction of the intestinal wall in CD (abscess, fistula) [5 years]
- Proportion of patients developing a cancer [5 years]
- Readmission rates for acute severe colitis or ileitis [5 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age>=18 years
-
Patients with an established diagnosis of CD or UC (clinical, biological, radiological, endoscopic or histologic criteria)
-
Patients >=45 kg
-
Affiliated member of the Social Security system
Exclusion Criteria:
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Patients with an undetermined colitis
-
Patients with a non established diagnosis of CD
-
Women of childbearing age without a method of contraception
-
Persons covered by articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code
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Pregnant women, breastfeeding women
-- Age < 18 years
-
Persons under legal protection
-
Person who does not have the capacity to consent
-
Persons under the age of 18 years who are deprived of their liberty by decision of a judicial or administrative authority (articles L. 3212-1 and L. 3213-1).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHRU Nancy | Vandœuvre-lès-Nancy | France | 54510 |
Sponsors and Collaborators
- Central Hospital, Nancy, France
Investigators
- Principal Investigator: Adeline GERMAIN, MD, PhD, CHRU Nancy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PSS 2018 / I-BANK-GERMAIN / MS