IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE

Not Applicable

Recruiting

• Conditions: Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease
• Interventions: Procedure: endoscopic biopsy; Procedure: samples of the oral cavity; Procedure: Samples of the resected specimen

• Registration Number: NCT03809728
• Lead Sponsor: Central Hospital, Nancy, France

Brief 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).

Study Timeline

• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-18
• Study Start: 2019-12-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Primary Completion: 2034-12-10
• Study Completion: 2034-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IBD patients	samples of the oral cavity	All patients with an established Crohn's disease or ulcerative colitis
IBD patients	endoscopic biopsy	All patients with an established Crohn's disease or ulcerative colitis
IBD patients	Samples of the resected specimen	All patients with an established Crohn's disease or ulcerative colitis

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Post-operative morbidity rates in IBD	5 years
Proportion of patients who underwent surgery	5 years
Proportion of patients with a destruction of the intestinal wall in CD (abscess, fistula)	5 years
Readmission rates for acute severe colitis or ileitis	5 years
Surgical recurrent rate in Crohn's disease	5 years
Proportion of patients developing a cancer	5 years

Trial Locations

Locations (1)

CHRU Nancy; 🇫🇷 Vandœuvre-lès-Nancy, France