IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE

Ulcerative Colitis Clinical Trial

— i-BANK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03809728
• Other study ID #: PSS 2018 / I-BANK-GERMAIN / MS
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: December 10, 2034

Study information

• Verified date: February 2024
• Source: Central Hospital, Nancy, France
• Contact: Adeline GERMAIN, MD, PhD
• Phone: +33383153120
• Email: a.germain[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 10, 2034
• Est. primary completion date: December 10, 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Procedure:
• endoscopic biopsy
Per-endoscopic biopsies
• samples of the oral cavity
7 samples of the oral cavity with a swab
• 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

Locations

Country	Name	City	State
France	CHRU Nancy	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

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