IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE (i-BANK)

Central Hospital, Nancy, France

Status: Enrolling

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Procedure: Samples of the resected specimen; Procedure: samples of the oral cavity; Procedure: endoscopic biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03809728

PSS 2018 / I-BANK-GERMAIN / MS

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

IBD patients

Other group

Description:

All patients with an established Crohn's disease or ulcerative colitis

Treatment:

Procedure: Samples of the resected specimen

Procedure: samples of the oral cavity

Procedure: endoscopic biopsy