IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE
NCT ID: NCT03809728
Last Updated: 2024-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1000 participants
INTERVENTIONAL
2019-12-10
2034-12-10
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IBD patients
All patients with an established Crohn's disease or ulcerative colitis
endoscopic biopsy
Per-endoscopic biopsies
samples of the oral cavity
7 samples of the oral cavity with a swab
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
Interventions
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endoscopic biopsy
Per-endoscopic biopsies
samples of the oral cavity
7 samples of the oral cavity with a swab
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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).
18 Years
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Dr Laurent PEYRIN-BIROULET
Doctor
Principal Investigators
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Adeline GERMAIN, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHRU Nancy
Locations
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CHRU Nancy
Vandœuvre-lès-Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PSS 2018 / I-BANK-GERMAIN / MS
Identifier Type: -
Identifier Source: org_study_id
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