Noninvasive BiomarkersFOCUS-UCNCT07402135
Fecal Noninvasive Biomarkers Oriented Control Versus Usual Care Strategy in Ulcerative Colitis
A study testing Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder: and Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1). in people with Noninvasive Biomarkers and Ulcerative Colitis (UC), run by Qilu Hospital of Shandong University.
Trial summary
Design: Multicenter, Open-Label, Randomized, Parallel Controlled Allocation: 1:1 Randomization Masking: Open-label (outcome assessors blinded for endoscopy) Primary Purpose: Treatment Strategy Evaluation Phase: Phase IV (Post-Marketing Surveillance) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Noninvasive Biomarkers, Ulcerative Colitis (UC)
- What is being tested?
- Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder: and Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1).
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2026to 31 Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- Confirmed UC diagnosis ≥6 months.
- Clinical remission: Partial Mayo Score (pMS) ≤2, with stool frequency and rectal bleeding subscores ≤1.
- Endoscopic remission (MES ≤1) confirmed by colonoscopy within 12 weeks pre-screening.
- Stable maintenance therapy (5-ASA, immunomodulators, biologics, or JAK inhibitors) ≥8 weeks.
- Written informed consent.
Who cannot join
- Indeterminate colitis or Crohn's disease.
- History of toxic megacolon, symptomatic colonic stricture, or dysplasia. Prior colectomy.
- Systemic/local corticosteroid use within 8 weeks.
- Active gastrointestinal infection or chronic diarrhea from non-UC causes.
- Pregnancy, lactation, or concurrent interventional trial participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Fecal Noninvasive Biomarkers Oriented Control Versus Usual Care Strategy in Ulcerative Colitis: A Multicenter, Open-Label, Randomized, Parallel Controlled Clinical Trial
Design: Multicenter, Open-Label, Randomized, Parallel Controlled Allocation: 1:1 Randomization Masking: Open-label (outcome assessors blinded for endoscopy) Primary Purpose: Treatment Strategy Evaluation Phase: Phase IV (Post-Marketing Surveillance)
- Conditions
- Noninvasive Biomarkers, Ulcerative Colitis (UC)
- Being tested
- Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder:, Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1).
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder:Procedure or surgery
Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder:
Level 0: Current maintenance therapy. Level 1: Optimize current therapy (e.g., dose increase, TDM-guided adjustment). Level 2: Add combination therapy (e.g., biologics + immunomodulators). Level 3: Switch to advanced therapy (different mechanism). Level 4: Study withdrawal (treatment failure).
Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1).Procedure or surgery
Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1).
| Study group | Role | What they receive |
|---|---|---|
| Tight Control (TC) Strategy | Experimental | Fecal calprotectin (FC) and FIT measured at Weeks 0, 12, 24, 36.
Action: Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder:
Level 0: Current maintenance therapy. Level 1: Optimize current therapy (e.g., dose increase, TDM-guided adjustment). Level 2: Add combination therapy (e.g., biologics + immunomodulators). Level 3: Switch to advanced therapy (different mechanism). Level 4: Study withdrawal (treatment failure). Receives: Procedure: Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder: |
| Conventional Management (CM) Strategy | Placebo comparator | Not described Receives: Procedure: Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Treatment Failure (Composite)
Time to Treatment Failure (Composite):
Clinical relapse (pMS increase ≥2 + rectal bleeding ≥1). Need for corticosteroids due to UC relapse. UC-related hospitalization or surgery. Endoscopic worsening (MES >1).
Measured: week 52
Secondary outcomes (1)
Endoscopic remission rate (MES ≤1).
Measured: week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start10 Feb 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noninvasive BiomarkersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
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, Weihai Municipal Hospital, Jining First People's Hospital, Zaozhuang Municipal Hospital, Liaocheng People's Hospital, Weifang People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402135
- Sponsor's protocol ID
- QILUGI-002
- Acronym
- FOCUS-UC
- Status last verified
- Feb 2026
- First submitted
- 30 Jul 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Noninvasive Biomarkers Oriented Control Versus Usual Care Strategy in Ulcerative Colitis: A Multicenter, Open-Label, Randomized, Parallel Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07402135
- Acronym / sponsor ID
- FOCUS-UC / QILUGI-002
- Conditions
- Noninvasive Biomarkers, Ulcerative Colitis (UC)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 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, Weihai Municipal Hospital, Jining First People's Hospital, Zaozhuang Municipal Hospital, Liaocheng People's Hospital, Weifang People's Hospital
- Study start
- 10 Feb 2026 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Feb 2026 (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.
Design: Multicenter, Open-Label, Randomized, Parallel Controlled Allocation: 1:1 Randomization Masking: Open-label (outcome assessors blinded for endoscopy) Primary Purpose: Treatment Strategy Evaluation Phase: Phase IV (Post-Marketing Surveillance)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tight Control (TC) Strategy | Experimental | Procedure: Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder:Fecal calprotectin (FC) and FIT measured at Weeks 0, 12, 24, 36. Action: Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder: Level 0: Current maintenance therapy. Level 1: Optimize current therapy (e.g., dose increase, TDM-guided adjustment). Level 2: Add combination therapy (e.g., biologics + immunomodulators). Level 3: Switch to advanced therapy (different mechanism). Level 4: Study withdrawal (treatment failure). |
| Conventional Management (CM) Strategy | Placebo comparator | Procedure: Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed UC diagnosis ≥6 months.
- Clinical remission: Partial Mayo Score (pMS) ≤2, with stool frequency and rectal bleeding subscores ≤1.
- Endoscopic remission (MES ≤1) confirmed by colonoscopy within 12 weeks pre-screening.
- Stable maintenance therapy (5-ASA, immunomodulators, biologics, or JAK inhibitors) ≥8 weeks.
- Written informed consent.
Key exclusion criteria (5 listed)
- Indeterminate colitis or Crohn's disease.
- History of toxic megacolon, symptomatic colonic stricture, or dysplasia. Prior colectomy.
- Systemic/local corticosteroid use within 8 weeks.
- Active gastrointestinal infection or chronic diarrhea from non-UC causes.
- Pregnancy, lactation, or concurrent interventional trial participation.
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 |
|---|---|---|
| Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder:Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder: Level 0: Current maintenance therapy. Level 1: Optimize current therapy (e.g., dose increase, TDM-guided adjustment). Level 2: Add combination therapy (e.g., biologics + immunomodulators). Level 3: Switch to advanced therapy (different mechanism). Level 4: Study withdrawal (treatment failure). | Procedure or surgery | Tight Control (TC) Strategy |
| Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1).Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1). | Procedure or surgery | Conventional Management (CM) Strategy |
Primary outcome
Time to Treatment Failure (Composite)
Time frame: week 52
Time to Treatment Failure (Composite): Clinical relapse (pMS increase ≥2 + rectal bleeding ≥1). Need for corticosteroids due to UC relapse. UC-related hospitalization or surgery. Endoscopic worsening (MES >1).
1 secondary outcome
Endoscopic remission rate (MES ≤1).
Time frame: 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 11 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder: and Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1). in people with Noninvasive Biomarkers and Ulcerative Colitis (UC), run by Qilu Hospital of Shandong University.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Time to Treatment Failure (Composite) (time frame: week 52). 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 11 Feb 2026.