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Study identifier: NCT07111273 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Ulcerative Colitis (UC) · Fecal Calprotetin · FIT  ·  Sponsor: Qilu Hospital of Shandong University

PhaseN/A
Planned participants100
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Yan Zhang, M.D.  ·  +86 18560089821  ·  qlzhangyan@sdu.edu.cn

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Locations (1)

Shandong UniversityJinan, Shandong, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07111273