Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07111273

DYNAMIC-UC: Early qFIT and Calprotectin Change Predicting Relapse in Biologic-Naive Ulcerative Colitis

Sponsor: Qilu Hospital of Shandong University

View on ClinicalTrials.gov

Summary

This multicenter prospective cohort study aims to evaluate whether a \>50% decrease or normalization of both quantitative fecal immunochemical test (qFIT) and fecal calprotectin (FC) levels at 2 weeks after starting conventional therapy (mesalazine or corticosteroids) can predict clinical relapse or need for biologic/JAK inhibitor therapy escalation by 52 weeks in biologic-naive patients with active ulcerative colitis (UC). Secondary objectives include assessing predictive value at 4 weeks, building dynamic prediction models, conducting health economic evaluation (Number Needed to Test, NNT), and exploring baseline predictors of early biomarker response. Patients will be observed during standard care with stool samples collected at Weeks 0, 2, and 4. Biomarker results will be blinded to clinicians/patients until study completion.

Official title: Diagnostic Value of Quantitative Fecal Immunochemical Test (qFIT) and Calprotectin (FC) Dynamic Changes at 2 Weeks for Predicting 52-Week Relapse or Treatment Escalation in Biologic-Naive Ulcerative Colitis: A Multicenter, Prospective Cohort Study (DYNAMIC-UC)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2025-08-01

Completion Date

2026-12-30

Last Updated

2025-08-08

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

FC and FIT TEST at WEEK0 2 4

FC and FIT TEST at WEEK0 2 4

Locations (1)

Shandong University

Jinan, Shandong, China