NCT07111273Recruiting
DYNAMIC-UC: Early qFIT and Calprotectin Change Predicting Relapse in Biologic-Naive Ulcerative Colitis
Diagnostic Value of Quantitative Fecal Immunochemical Test (qFIT) and Calprotectin (FC) Dynamic Changes at 2 Weeks for Predicting 52-Week Relapse or Treatment Escalation in Biologic-Naive Ulcerative Colitis: A Multicenter, Prospective Cohort Study (DYNAMIC-UC)
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 30 Jul 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Qilu Hospital of Shandong University
- Diseases
- Ulcerative colitis
- NCT number
- NCT07111273
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Aug 2025 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
- Any other condition deemed by the investigator to make the patient unsuitable for study participation.
Other
- Regular use of antiplatelet agents (e.g., aspirin, clopidogrel) or anticoagulants (e.g., warfarin, rivaroxaban).
- Pregnancy or lactation.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shandong University Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.