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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Procedure: endoscopic biopsy; Procedure: samples of the oral cavity; Procedure: Samples of the resected specimen

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 Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adeline GERMAIN, MD, PhD; Phone Number: +33383153120; Email: a.germain@chru-nancy.fr

Study Locations

• France
  • Vandœuvre-lès-Nancy, France, 54510
    • Recruiting
    • CHRU Nancy
    • Sub-Investigator: Laurent BRESLER, MD
    • Sub-Investigator: Laurent PEYRIN-BIROULET, MD, PhD
    • Principal Investigator: Adeline GERMAIN, MD,PhD
    • Sub-Investigator: Camille ZALLOT, MD
    • Sub-Investigator: Marine FERRY, MD
    • Contact: Marine BECK; Phone Number: +33383155280; Email: m.beck@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab).	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Proportion of patients developing a cancer	5 years
Readmission rates for acute severe colitis or ileitis	5 years
Proportion of patients with a destruction of the intestinal wall in CD (abscess, fistula)	5 years

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Adeline GERMAIN, MD, PhD, CHRU Nancy

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Estimated): December 10, 2034
• Study Completion (Estimated): December 10, 2034

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases
• Other Study ID Numbers: PSS 2018 / I-BANK-GERMAIN / MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No