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Clinical Trials in France / NCT03809728
Recruiting Not applicable

IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE

NCT03809728 · tracked via the Priya Life Science France tracker
Sponsor
Central Hospital, Nancy, France
Phase
Not applicable
Started
2019-12-10
Last updated
2024-02-07

Condition(s) studied

Inflammatory Bowel DiseasesCrohn DiseaseUlcerative Colitis

Investigational drug(s) / intervention(s)

endoscopic biopsysamples of the oral cavitySamples of the resected specimen

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
CHRU Nancy Vandœuvre-lès-Nancy France Recruiting

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Other trials for the same condition

A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC Active, not recruiting
A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease Recruiting
A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis Recruiting
Intertriginous/Periorificial Dermatoses in Patients With IBD on Anti-TNFα: Relative Abundance of Staphylococcus Aureus Within the Lesion Microbiota and Clinical Correlation (micSPIDER). Starting soon
Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis. Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03809728 on ClinicalTrials.gov ↗ ← All trials in France