RecruitingNot ApplicableNCT03809728

IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE

IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS OF NATURAL HISTORY AND RESPONSE TO BIOTHERAPIES IN INFLAMMATORY BOWEL DISEASE : i-BANK


Sponsor

Central Hospital, Nancy, France

Enrollment

1,000 participants

Start Date

Dec 10, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

Interventional study of a group of patients with an inflammatory bowel disease (IBD; Crohn's disease (CD) or ulcerative colitis (UC)) to identify predictive and prognostic biomarkers of natural history and response to biotherapies.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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
  • 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).

Interventions

PROCEDUREendoscopic biopsy

Per-endoscopic biopsies

PROCEDUREsamples of the oral cavity

7 samples of the oral cavity with a swab

PROCEDURESamples 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


Locations(1)

CHRU Nancy

Vandœuvre-lès-Nancy, France

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NCT03809728


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