NCT05456893

A Study to Evaluate Biomarkers in Moderate to Severe Ulcerative Colitis (UC) Patients Treated With Different Targeted Therapies

A Multicentre Prospective Longitudinal Observational Study to Evaluate Biomarkers in Moderate to Severe Ulcerative Colitis (UC) Patients Treated With Different Targeted Therapies

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 95 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
PROCEDURE	Procedure: endoscopic biopsy	Per-endoscopic biopsies
PROCEDURE	Blood sampling	Blood sampling
PROCEDURE	stool sampling	stool sampling

Timeline

• Start date: 2022-07-28
• Primary completion: 2027-09-09
• Completion: 2027-09-09
• First posted: 2022-07-13
• Last updated: 2025-05-06

Locations

1 site across 1 country: France