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

NCT07111273 | Not Yet Recruiting DMC

• 2 other identifiers: QILUGI-001QILUGILAB
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis (UC); Fecal Calprotetin; FIT; Biomarker

Keywords

ulcerative colitis; fecal calprotectin; FIT; biologic-naive

Outcome Measures

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.

  From enrollment to Week 52 (±2 weeks)

Secondary Outcomes (5)

• Time to First Composite Endpoint Event

  From enrollment to Week 52 (±2 weeks)

• Proportion with Corticosteroid-Free Clinical Remission

  Week 52 (±2 weeks)

• Diagnostic Performance (AUC) of Week 2 Biomarker Response

  Week 2 prediction assessed at Week 52

• Number Needed to Test (NNT)

  Week 52 (±2 weeks)

• Diagnostic Performance (AUC) of Biomarker Change Slope Models

  Weeks 0-2 and Weeks 0-4 slopes assessed at Week 52

Interventions

FC and FIT TEST at WEEK0 2 4 DIAGNOSTIC_TEST

FC and FIT TEST at WEEK0 2 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Ulcerative Colitis patints come to clinic or ward of hospitals.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• 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

Study Sites (1)

Shandong University

Jinan, Shandong, 250000, China

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Yan Zhang, M.D.

CONTACT

+86 18560089821; qlzhangyan@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 8, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

CN (1)