NCT03809728

IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Inflammatory Bowel Diseases
• Crohn Disease
• Ulcerative Colitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-12-10
• Primary completion: 2034-12-10
• Completion: 2034-12-10
• First posted: 2019-01-18
• Last updated: 2024-02-07

Locations

1 site across 1 country: France