IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS IN INFLAMMATORY BOWEL DISEASE
Not applicable · Testing endoscopic biopsy, samples of the oral cavity and Samples of the resected specimen · 1 site · Central Hospital, Nancy, France
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing endoscopic biopsy (a procedure), samples of the oral cavity (a procedure) and Samples of the resected specimen (a procedure) as a possible treatment. Condition(s) listed: Inflammatory Bowel Diseases, Crohn Disease and Ulcerative Colitis.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Age>=18 years
- Patients with an established diagnosis of CD or UC (clinical, biological, radiological, endoscopic or histologic criteria)
- Patients >=45 kg
Plus 1 more requirement(s). There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 1000 participants are expected to take part.
- Start date: 2019-12-10.
- Main results expected around 2034-12-10 (estimate from the record).
- 1 study site listed (1 marked recruiting) in France.
Main thing being measured
- Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab). (5 years)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis |
| Lead sponsor | Central Hospital, Nancy, France |
| Enrollment | 1000 (estimated) |
| Start date | 2019-12-10 |
| Primary completion (est.) | 2034-12-10 |
| First posted | 2019-01-18 |
| Last updated | 2024-02-07 |
| Official title | IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS OF NATURAL HISTORY AND RESPONSE TO BIOTHERAPIES IN INFLAMMATORY BOWEL DISEASE : i-BANK |
| ClinicalTrials.gov ID | NCT03809728 |
Interventions
- endoscopic biopsy (Procedure)
Per-endoscopic biopsies - samples of the oral cavity (Procedure)
7 samples of the oral cavity with a swab - Samples of the resected specimen (Procedure)
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
Full eligibility criteria (from the record)
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).
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| CHRU Nancy | Vandœuvre-lès-Nancy | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.