Identifying biomarkers in inflammatory bowel disease
IDENTIFICATION OF PROGNOSTIC AND PREDICTIVE BIOMARKERS OF NATURAL HISTORY AND RESPONSE TO BIOTHERAPIES IN INFLAMMATORY BOWEL DISEASE : i-BANK
This study is trying to find specific markers in people with Crohn's disease and ulcerative colitis that can help predict how their disease will progress and how well they will respond to new treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Drugs / interventions | ustekinumab, vedolizumab |
| Locations | 1 site (Vandœuvre-lès-Nancy) |
| Trial ID | NCT03809728 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with inflammatory bowel diseases, specifically Crohn's disease and ulcerative colitis, to identify biomarkers that can predict disease progression and response to biotherapies. It evaluates treatment responses through various objective measures, including endoscopic, radiological, and biological assessments. The study also correlates treatment outcomes with genomic, epigenomic, and microbiota data, taking into account environmental factors such as nutrition and physical activity.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of Crohn's disease or ulcerative colitis.
Not a fit: Patients with undetermined colitis or those without an established diagnosis of Crohn's disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for patients with inflammatory bowel diseases.
How similar studies have performed: Other studies have shown promise in identifying biomarkers for inflammatory bowel diseases, suggesting that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Vandœuvre-lès-Nancy
- CHRU Nancy — Vandœuvre-lès-Nancy, France (Recruiting)
Study contacts
- Principal investigator: Adeline GERMAIN, MD, PhD — CHRU Nancy
- Study coordinator: Adeline GERMAIN, MD, PhD
- Email: a.germain@chru-nancy.fr
- Phone: +33383153120
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.