Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:52 PM
Study NCT ID:
NCT07402135
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-11
First Post:
2025-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fecal Noninvasive Biomarkers Oriented Control Versus Usual Care Strategy in Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2025-07-30', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Treatment Failure (Composite)', 'timeFrame': 'week 52', 'description': 'Time to Treatment Failure (Composite):\n\nClinical relapse (pMS increase ≥2 + rectal bleeding ≥1). Need for corticosteroids due to UC relapse. UC-related hospitalization or surgery. Endoscopic worsening (MES \\>1).'}], 'secondaryOutcomes': [{'measure': 'Endoscopic remission rate (MES ≤1).', 'timeFrame': 'week 52'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Noninvasive Biomarkers', 'Ulcerative Colitis (UC)']}, 'descriptionModule': {'briefSummary': '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)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Confirmed UC diagnosis ≥6 months.\n2. Clinical remission: Partial Mayo Score (pMS) ≤2, with stool frequency and rectal bleeding subscores ≤1.\n3. Endoscopic remission (MES ≤1) confirmed by colonoscopy within 12 weeks pre-screening.\n4. Stable maintenance therapy (5-ASA, immunomodulators, biologics, or JAK inhibitors) ≥8 weeks.\n5. Written informed consent.\n\nExclusion Criteria:\n\n1. Indeterminate colitis or Crohn's disease.\n2. History of toxic megacolon, symptomatic colonic stricture, or dysplasia. Prior colectomy.\n3. Systemic/local corticosteroid use within 8 weeks.\n4. Active gastrointestinal infection or chronic diarrhea from non-UC causes.\n5. Pregnancy, lactation, or concurrent interventional trial participation."}, 'identificationModule': {'nctId': 'NCT07402135', 'acronym': 'FOCUS-UC', 'briefTitle': 'Fecal Noninvasive Biomarkers Oriented Control Versus Usual Care Strategy in Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'Fecal Noninvasive Biomarkers Oriented Control Versus Usual Care Strategy in Ulcerative Colitis: A Multicenter, Open-Label, Randomized, Parallel Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'QILUGI-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tight Control (TC) Strategy', 'description': 'Fecal calprotectin (FC) and FIT measured at Weeks 0, 12, 24, 36.\n\nAction: Preemptive therapy escalation based on preset thresholds (FC \\>250 μg/g or FIT \\>100 ng/mL) using the FOCUS-UC Ladder:\n\nLevel 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).', 'interventionNames': ['Procedure: Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder:']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Conventional Management (CM) Strategy', 'interventionNames': ['Procedure: Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1).']}], 'interventions': [{'name': 'Preemptive therapy escalation based on preset thresholds (FC >250 μg/g or FIT >100 ng/mL) using the FOCUS-UC Ladder:', 'type': 'PROCEDURE', 'description': 'Preemptive therapy escalation based on preset thresholds (FC \\>250 μg/g or FIT \\>100 ng/mL) using the FOCUS-UC Ladder:\n\nLevel 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).', 'armGroupLabels': ['Tight Control (TC) Strategy']}, {'name': 'Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1).', 'type': 'PROCEDURE', 'description': 'Therapy adjustment only upon clinical relapse (pMS increase ≥2 + rectal bleeding score ≥1).', 'armGroupLabels': ['Conventional Management (CM) Strategy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yan Zhang, M.D', 'role': 'CONTACT', 'email': 'qlzhangyan@sdu.edu.cn', 'phone': '+86 18560089821'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Qilu Hospital of Shandong University (Qingdao)', 'class': 'OTHER'}, {'name': 'Dezhou Hospital Qilu Hospital of Shandong University', 'class': 'OTHER'}, {'name': 'Weihai Municipal Hospital', 'class': 'OTHER'}, {'name': "Jining First People's Hospital", 'class': 'OTHER'}, {'name': 'Zaozhuang Municipal Hospital', 'class': 'OTHER'}, {'name': "Liaocheng People's Hospital", 'class': 'OTHER'}, {'name': "Weifang People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}