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| ID | Type | Description | Link |
|---|---|---|---|
| QILUGILAB | Registry Identifier | DYNAMIC-UC |
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| Name | Class |
|---|---|
| Qilu Hospital of Shandong University (Qingdao) | OTHER |
| Dezhou Hospital Qilu Hospital of Shandong University | OTHER |
| JiNing NO.1 People Hospital | UNKNOWN |
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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 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FC and FIT TEST at WEEK0 2 4 | Diagnostic Test | FC and FIT TEST at WEEK0 2 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to Week 52 (±2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Composite Endpoint Event | From enrollment to Week 52 (±2 weeks) | |
| Proportion with Corticosteroid-Free Clinical Remission | Partial Mayo Score ≤1 point without corticosteroid use for ≥4 weeks. |
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Inclusion Criteria:
Willing and able to provide written informed consent.
Exclusion Criteria:
Presence of other conditions clearly causing intestinal bleeding (e.g., acute hemorrhoidal bleeding, colorectal cancer, large colorectal polyps >1cm, intestinal vascular malformations).
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Ulcerative Colitis patints come to clinic or ward of hospitals.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Zhang, M.D. | Contact | +86 18560089821 | qlzhangyan@sdu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong University | Jinan | Shandong | 250000 | China |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Zaozhuang Municipal Hospital |
| OTHER |
| caoxian chinese medicine hospital | UNKNOWN |
| longkou chinsese medicine hospital | UNKNOWN |
| Shouguang people's Hospital | UNKNOWN |
| Weihai Municipal Hospital | OTHER |
| Liaocheng People's Hospital | OTHER |
| ZhangQiu Yile Hospital | UNKNOWN |
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| Week 52 (±2 weeks) |
| 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. | Week 2 prediction assessed at Week 52 |
| Number Needed to Test (NNT) | NNT = 1 / [Event Rate (Group B) - Event Rate (Group A)] for the composite endpoint at Week 52. | Week 52 (±2 weeks) |
| Diagnostic Performance (AUC) of Biomarker Change Slope Models | 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. | Weeks 0-2 and Weeks 0-4 slopes assessed at Week 52 |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |