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Recruiting NCT03809728

IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE

No phase Interventional Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: endoscopic biopsy, samples of the oral cavity, Samples of the resected specimen.
Who it may be relevant to
Registry conditions: Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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).

Interventions

  • 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

Primary outcome measures

  • Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab). [Time frame: 5 years]
Secondary outcome measures (6)
  • Proportion of patients who underwent surgery [Time frame: 5 years]
  • Post-operative morbidity rates in IBD [Time frame: 5 years]
  • Surgical recurrent rate in Crohn's disease [Time frame: 5 years]
  • Proportion of patients with a destruction of the intestinal wall in CD (abscess, fistula) [Time frame: 5 years]
  • Proportion of patients developing a cancer [Time frame: 5 years]
  • Readmission rates for acute severe colitis or ileitis [Time frame: 5 years]

Eligibility 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

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • CHRU Nancy — Vandœuvre-lès-Nancy

Identifiers

NCT: NCT03809728 · PSS 2018 / I-BANK-GERMAIN / MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗