Ulcerative Colitis (UC)DYNAMIC-UCNCT07111273
DYNAMIC-UC: Early qFIT and Calprotectin Change Predicting Relapse in Biologic-Naive Ulcerative Colitis
An observational study of Ulcerative Colitis (UC) and Fecal Calprotetin, run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis (UC), Fecal Calprotetin, FIT
- What is being tested?
- FC and FIT TEST at WEEK0 2 4
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 30 Dec 2026
- How long will I take part?
- 14 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ulcerative Colitis patints come to clinic or ward of hospitals.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong University
Jinan, Shandong, 250000
Yan Zhang, MD., +8613165133773, qlzhangyan@sdu.edu.cn
About this study
Official title: 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)
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.
Read the 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.
- Conditions
- Ulcerative Colitis (UC), Fecal Calprotetin, FIT, Biomarker
- Being tested
- FC and FIT TEST at WEEK0 2 4
- Keywords
- ulcerative colitis, fecal calprotectin, FIT, biologic-naive
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FC and FIT TEST at WEEK0 2 4Diagnostic test
FC and FIT TEST at WEEK0 2 4
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to Week 52 (±2 weeks)
Secondary outcomes (5)
Time to First Composite Endpoint Event
Measured: From enrollment to Week 52 (±2 weeks)
Proportion with Corticosteroid-Free Clinical Remission
Partial Mayo Score ≤1 point without corticosteroid use for ≥4 weeks.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 0-2 and Weeks 0-4 slopes assessed at Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Aug 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 14 Weeks
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Hospital of Shandong University (Qingdao), Dezhou Hospital Qilu Hospital of Shandong University, JiNing NO.1 People Hospital, Zaozhuang Municipal Hospital, caoxian chinese medicine hospital, longkou chinsese medicine hospital, Shouguang People's Hospital, Weihai Municipal Hospital, Liaocheng People's Hospital, ZhangQiu Yile Hospital
- Responsible party
- Principal investigator, Yan Zhang, MD, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111273
- Sponsor's protocol ID
- QILUGI-001
- Other IDs
- QILUGILAB
- Acronym
- DYNAMIC-UC
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07111273
- Acronym / sponsor ID
- DYNAMIC-UC / QILUGI-001
- Conditions
- Ulcerative Colitis (UC), Fecal Calprotetin, FIT, Biomarker
- Keywords
- ulcerative colitis, fecal calprotectin, FIT, biologic-naive
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Qilu Hospital of Shandong University (Qingdao), Dezhou Hospital Qilu Hospital of Shandong University, JiNing NO.1 People Hospital, Zaozhuang Municipal Hospital, caoxian chinese medicine hospital, longkou chinsese medicine hospital, Shouguang People's Hospital, Weihai Municipal Hospital, Liaocheng People's Hospital, ZhangQiu Yile Hospital
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Weeks
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ulcerative Colitis patints come to clinic or ward of hospitals.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FC and FIT TEST at WEEK0 2 4FC and FIT TEST at WEEK0 2 4 | Diagnostic test | – |
Primary outcome
Composite Endpoint Rate (Clinical Relapse OR Treatment Escalation)
Time frame: 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.
5 secondary outcomes
Time to First Composite Endpoint Event
Time frame: From enrollment to Week 52 (±2 weeks)
Proportion with Corticosteroid-Free Clinical Remission
Time frame: Week 52 (±2 weeks)
Diagnostic Performance (AUC) of Week 2 Biomarker Response
Time frame: Week 2 prediction assessed at Week 52
Number Needed to Test (NNT)
Time frame: Week 52 (±2 weeks)
Diagnostic Performance (AUC) of Biomarker Change Slope Models
Time frame: Weeks 0-2 and Weeks 0-4 slopes assessed at Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis (UC) and Fecal Calprotetin, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Zhang, M.D. (+86 18560089821, qlzhangyan@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Endpoint Rate (Clinical Relapse OR Treatment Escalation) (time frame: From enrollment to Week 52 (±2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.