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RECRUITING
NCT07686406

IBD Biomarker Discovery and Validation Platform

Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

View on ClinicalTrials.gov

Summary

The goal of this observational study is to establish a multicenter prospective clinical and biospecimen platform for biomarker discovery and validation in inflammatory bowel disease, including Crohn's disease and ulcerative colitis. Researchers want to learn whether candidate biomarkers or combined biomarker models can help assess intestinal inflammation, monitor response to routine clinical treatment, predict treatment outcomes, and identify participants who may be at higher risk of disease progression. The study may enroll participants with inflammatory bowel disease, unaffected first-degree relatives of participants with inflammatory bowel disease, unrelated healthy controls, and non-IBD disease controls when appropriate. Clinical information and biological samples, including blood, stool, and intestinal tissue, may be collected. Biomarkers measured in blood, stool, intestinal tissue, genetic data, immune profiles, microbiome data, and other multi-omics data may be evaluated. The main questions this study aims to answer are: Can candidate biomarkers or combined biomarker models identify endoscopic disease activity when compared with endoscopic assessment? Can these biomarkers monitor or predict clinical response, clinical remission, endoscopic response, endoscopic remission, imaging response, or biomarker response during routine clinical care? Can these biomarkers help predict treatment failure, disease progression, hospitalization, surgery, treatment escalation, or complex Crohn's disease phenotypes? Participants will not be assigned to any treatment by the study. All treatments and clinical management decisions will be chosen by treating physicians as part of routine medical care.

Official title: Biomarker Discovery, Validation, and Multi-Omics Profiling for Disease Activity Assessment, Treatment Monitoring, and Risk Stratification in Inflammatory Bowel Disease: A Multicenter Prospective Biospecimen-Based Observational Cohort Study

Key Details

Gender

All

Age Range

14 Years - Any

Study Type

OBSERVATIONAL

Enrollment

6000

Start Date

2022-01-01

Completion Date

2028-12-31

Last Updated

2026-07-07

Healthy Volunteers

Yes

Locations (2)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China