DYNAMIC-UC: Early qFIT and Calprotectin Change Predicting Relapse in Biologic-Naive Ulcerative Colitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorQilu Hospital of Shandong University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years.
Established diagnosis of Ulcerative Colitis (UC) confirmed by clinical, endoscopic, and histopathological criteria.
Endoscopic disease activity (Mayo Endoscopic Subscore ≥ 2) confirmed by colonoscopy during screening.
Biologic-naive (no prior exposure to any biologic agent [e.g., infliximab, adalimumab, vedolizumab, ustekinumab] or JAK inhibitor).
Disqualifiers
Diagnosis or high suspicion of Crohn's disease, ischemic colitis, infectious colitis, radiation colitis, intestinal tuberculosis, or other types of colitis.
Untreated systemic conditions that may cause intestinal bleeding (e.g., thrombocytopenia [PLT <50 x 10^9/L], severe coagulopathy).
Regular use of antiplatelet agents (e.g., aspirin, clopidogrel) or anticoagulants (e.g., warfarin, rivaroxaban).
Pregnancy or lactation.
Trial population
Ulcerative Colitis patints come to clinic or ward of hospitals.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
FC and FIT TEST at WEEK0 2 4
Diagnostic testFC and FIT TEST at WEEK0 2 4
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Composite Endpoint Rate (Clinical Relapse OR Treatment Escalation)
Proportion of patients experiencing either: 1) Clinical Relapse: Increase ≥2 points in partial Mayo Score (stool frequency + rectal bleeding + PGA) with rectal bleeding subscore ≥1 requiring therapy adjustment, OR 2) Treatment Escalation: Initiation of any biologic agent (e.g., infliximab, adalimumab, vedolizumab, ustekinumab) or JAK inhibitor due to steroid-refractoriness (failure to respond by Week 4) or steroid-dependence (relapse during/after steroid taper within 3 months) as per standardized protocol.
Time frame
From enrollment to Week 52 (±2 weeks)Secondary outcomes
1
Time to First Composite Endpoint Event
Time frame
From enrollment to Week 52 (±2 weeks)2
Proportion with Corticosteroid-Free Clinical Remission
Partial Mayo Score ≤1 point without corticosteroid use for ≥4 weeks.
Time frame
Week 52 (±2 weeks)3
Diagnostic Performance (AUC) of Week 2 Biomarker Response
Area Under the Receiver Operating Characteristic Curve (AUC) for the Week 2 qFIT+FC combined response (Group A vs B) in predicting the Week 52 composite endpoint.
Time frame
Week 2 prediction assessed at Week 524
Number Needed to Test (NNT)
NNT = 1 / \[Event Rate (Group B) - Event Rate (Group A)\] for the composite endpoint at Week 52.
Time frame
Week 52 (±2 weeks)Sponsors and contacts
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Qilu Hospital of Shandong University
Lead sponsor
Qilu Hospital of Shandong University (Qingdao)
Collaborator
Dezhou Hospital Qilu Hospital of Shandong University
Collaborator
JiNing NO.1 People Hospital
Collaborator
Zaozhuang Municipal Hospital
Collaborator
caoxian chinese medicine hospital
Collaborator
longkou chinsese medicine hospital
Collaborator
Shouguang people's Hospital
Collaborator
Weihai Municipal Hospital
Collaborator
Liaocheng People's Hospital
Collaborator
ZhangQiu Yile Hospital
Collaborator
Source ClinicalTrials.gov