RecruitingNCT05456893

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

Sponsor

Central Hospital, Nancy, France

Enrollment

95 participants

Start Date

Jul 28, 2022

Study Type

OBSERVATIONAL

Conditions

Inflammatory Bowel Diseases Ulcerative Colitis

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study collects blood and tissue samples from people with moderate to severe ulcerative colitis (UC) — a chronic inflammatory bowel disease — who are starting a new biologic or small molecule treatment, to identify biomarkers (measurable signals in the blood or tissue) that predict which treatments will work best for which patients. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of ulcerative colitis - Your UC is moderate to severe and currently active (confirmed by colonoscopy) - Your doctor is starting you on a new biologic or targeted therapy for UC - You are willing to undergo a colonoscopy as part of standard care **You may NOT be eligible if...** - You have a different type of colitis (microscopic, infectious, ischemic, or radiation-related) - You have a contraindication to endoscopy - You have a bleeding disorder - You need immediate surgery for your UC - You are on rectal therapies (enemas or suppositories) in the 2 weeks before the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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