A Study to Evaluate Biomarkers in Moderate to Severe Ulcerative Colitis (UC) Patients Treated With Different Targeted Therapies
NCT05456893 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 95
Last updated 2025-05-06
Summary
UC is a chronic, idiopathic form of intestinal inflammatory disease (IBD) that affects the colon, most commonly afflicting adults aged 30-40 years and resulting in disability and lower quality of life (1). It is characterized by relapsing and remitting mucosal inflammation, starting in the rectum and extending to proximal segments of the colon. Although biologic therapies have provided clinical benefits to patients, these goals are still poorly met, due to the limited knowledge of the underlying mechanisms of immunopathology and the lack of predictive biomarkers that would allow proper patient stratification.
The hypothesis of this study is that by identifying new biomarkers in blood, stool and tissue that (i) predict response (or non-response) to therapy prior to the start of treatment and (ii) predict response to therapy in the early phase of treatment will allow to find the right treatment for the right patient (personalized medicine).
Conditions
- Ulcerative Colitis
- Inflammatory Bowel Diseases
Interventions
- PROCEDURE
-
Procedure: endoscopic biopsy
Per-endoscopic biopsies
- PROCEDURE
-
Blood sampling
Blood sampling
- PROCEDURE
-
stool sampling
stool sampling
Sponsors & Collaborators
-
Central Hospital, Nancy, France
lead OTHER
Principal Investigators
-
Stefan MD SCHREIBER, PhD · Christian Albrechts Universität
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-28
- Primary Completion
- 2027-09-09
- Completion
- 2027-09-09
Countries
- France
Study Locations
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