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

Not yet recruiting

• Conditions: Ulcerative Colitis (UC); Fecal Calprotetin; FIT; Biomarker

• Registration Number: NCT07111273
• Lead Sponsor: Qilu Hospital of Shandong University

Brief 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.

Detailed Description

This is a prospective, observational cohort study conducted across multiple centers in China. Biologic-naive UC patients (Mayo Endoscopic Subscore ≥2) initiating conventional therapy (mesalazine or corticosteroids) will be enrolled. Stool samples for quantitative FIT (qFIT) and fecal calprotectin (FC) will be collected at Baseline (Week 0) , Week 2 (±3 days) , and Week 4 (±3 days) . Patients are classified at Week 2:

Group A (Rapid Responders): Both qFIT \& FC decrease \>50% from baseline OR normalize.

Group B (Slow/Non-Responders): Either qFIT or FC decrease ≤50%. The primary endpoint is the composite event rate (clinical relapse OR treatment escalation to biologics/JAK inhibitors) by Week 52 (±2 weeks) . Clinical relapse is defined as an increase ≥2 points in partial Mayo score (excluding endoscopy) with a rectal bleeding subscore ≥1 requiring therapy adjustment. Treatment escalation occurs per standardized criteria (steroid-refractoriness or dependence). Secondary endpoints include time-to-event, corticosteroid-free remission, mucosal healing at Week 52, predictive model performance (AUC, sensitivity, specificity), NNT calculation, and baseline predictors.

Study Timeline

• Study First Submitted: 2025-07-30
• Status Verified: 2025-08
• Study Start: 2025-08-01
• Study First Submitted QC: 2025-08-06
• Last Update Submitted: 2025-08-06
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08
• Primary Completion: 2026-08-31
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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).
• No use of systemic corticosteroids (oral or intravenous) within 4 weeks prior to Baseline (Week 0) visit.
• If using oral or rectal mesalazine/5-ASA preparations, dose must have been stable for ≥2 weeks prior to Baseline (Week 0).

Willing and able to provide written informed consent.

Exclusion Criteria

• Diagnosis or high suspicion of Crohn's disease, ischemic colitis, infectious colitis, radiation colitis, intestinal tuberculosis, or other types of colitis.

Presence of other conditions clearly causing intestinal bleeding (e.g., acute hemorrhoidal bleeding, colorectal cancer, large colorectal polyps >1cm, intestinal vascular malformations).

• 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.
• Any other condition deemed by the investigator to make the patient unsuitable for study participation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite Endpoint Rate (Clinical Relapse OR Treatment Escalation)	From enrollment to Week 52 (±2 weeks)	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.

Secondary Outcome Measures

Name	Time	Method
Time to First Composite Endpoint Event	From enrollment to Week 52 (±2 weeks)
Number Needed to Test (NNT)	Week 52 (±2 weeks)	NNT = 1 / \[Event Rate (Group B) - Event Rate (Group A)\] for the composite endpoint at Week 52.
Diagnostic Performance (AUC) of Biomarker Change Slope Models	Weeks 0-2 and Weeks 0-4 slopes assessed at Week 52	AUC of logistic regression models using the rate of change (Δ/week) of FC and/or qFIT from Week 0 to Week 2 and/or Week 0 to Week 4 for predicting the Week 52 composite endpoint. Sensitivity, specificity, PPV, NPV will also be calculated.
Proportion with Corticosteroid-Free Clinical Remission	Week 52 (±2 weeks)	Partial Mayo Score ≤1 point without corticosteroid use for ≥4 weeks.
Diagnostic Performance (AUC) of Week 2 Biomarker Response	Week 2 prediction assessed at Week 52	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.

Trial Locations

Locations (1)

Shandong University; 🇨🇳 Jinan, Shandong, China