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

Primary Purpose

Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
endoscopic biopsy
samples of the oral cavity
Samples of the resected specimen
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • CHRU NancyRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

IBD patients

Arm Description

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

Outcomes

Primary Outcome Measures

Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab).

Secondary Outcome Measures

Proportion of patients who underwent surgery
Post-operative morbidity rates in IBD
Surgical recurrent rate in Crohn's disease
Propotion of patients with a destruction of the intestinal wall in CD (abscess, fistula)
Proportion of patients developing a cancer
Readmission rates for acute severe colitis or ileitis

Full Information

First Posted
January 17, 2019
Last Updated
February 8, 2023
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT03809728
Brief Title
IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE
Acronym
i-BANK
Official Title
IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS OF NATURAL HISTORY AND RESPONSE TO BIOTHERAPIES IN INFLAMMATORY BOWEL DISEASE : i-BANK
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
December 10, 2024 (Anticipated)
Study Completion Date
April 2, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Interventional study of a group of patients with an inflammatory bowel disease (Crohn's disease or ulcerative colitis) 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IBD patients
Arm Type
Other
Arm Description
All patients with an established Crohn's disease or ulcerative colitis
Intervention Type
Procedure
Intervention Name(s)
endoscopic biopsy
Intervention Description
Per-endoscopic biopsies
Intervention Type
Procedure
Intervention Name(s)
samples of the oral cavity
Intervention Description
7 samples of the oral cavity with a swab
Intervention Type
Procedure
Intervention Name(s)
Samples of the resected specimen
Intervention Description
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 Measure Information:
Title
Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab).
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Proportion of patients who underwent surgery
Time Frame
5 years
Title
Post-operative morbidity rates in IBD
Time Frame
5 years
Title
Surgical recurrent rate in Crohn's disease
Time Frame
5 years
Title
Propotion of patients with a destruction of the intestinal wall in CD (abscess, fistula)
Time Frame
5 years
Title
Proportion of patients developing a cancer
Time Frame
5 years
Title
Readmission rates for acute severe colitis or ileitis
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adeline GERMAIN, MD, PhD
Phone
+33383153120
Email
a.germain@chru-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adeline GERMAIN, MD, PhD
Organizational Affiliation
CHRU Nancy
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Nancy
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54510
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marjorie STARCK
Phone
+33383155273
Email
m.starck@chru-nancy.fr
First Name & Middle Initial & Last Name & Degree
Laurent PEYRIN-BIROULET, MD, PhD
First Name & Middle Initial & Last Name & Degree
Adeline GERMAIN, MD,PhD
First Name & Middle Initial & Last Name & Degree
Laurent BRESLER, MD
First Name & Middle Initial & Last Name & Degree
Camille ZALLOT, MD
First Name & Middle Initial & Last Name & Degree
Marine FERRY, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE

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