Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-08 @ 10:23 PM
Study NCT ID:
NCT05542459
Status:
UNKNOWN
Last Update Posted:
2022-09-15
First Post:
2022-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-omics to Predict Responses to Biologics in IBD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001688', 'term': 'Biological Products'}], 'ancestors': [{'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood, serum, white cells, urine, feces, tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1050}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-14', 'studyFirstSubmitDate': '2022-09-10', 'studyFirstSubmitQcDate': '2022-09-14', 'lastUpdatePostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical response', 'timeFrame': 'At week 14-26', 'description': "The reduction of Crohn's Disease Activity Index (CDAI) ≥70 or CDAI \\<150 for Crohn's disease; a reduction of the Mayo Clinical Score ≥2 for ulcerative colitis"}, {'measure': 'Mucosal healing', 'timeFrame': 'At week 42-64', 'description': 'Mucosal healing is defined as absence of mucosal ulceration'}], 'secondaryOutcomes': [{'measure': 'Clinical response rate with steroids or without steroids', 'timeFrame': 'At week 14-26 and week 42-64', 'description': 'Clinical response rate with steroids or without steroids at week 14-26 and week 42-64'}, {'measure': 'Clinical remission rate with steroids or without steroids', 'timeFrame': 'At week 14-26 and week 42-64', 'description': 'Clinical remission rate with steroids or without steroids at week 14-26 and week 42-64'}, {'measure': 'Objective response rate', 'timeFrame': 'At week 14-26 and week 42-64', 'description': 'Objective response was defined based on results obtained from at least 1 among endoscopy, bowel ultrasound, and computerized tomography (CT) or magnetic resonance (MR) enteroclysis at week 14-26 and week 42-64'}, {'measure': 'Objective remission rate', 'timeFrame': 'At week 14-26 and week 42-64', 'description': 'Objective remission was defined based on results obtained from at least 1 among endoscopy, bowel ultrasound, and computerized tomography (CT) or magnetic resonance (MR) enteroclysis at week 14-26 and week 42-64'}, {'measure': 'Inflammatory Bowel Disease Questionnaire (IBDQ) score', 'timeFrame': 'At baseline, week 14-26 and week 42-64', 'description': 'IBDQ score at baseline, week 14-26 and week 42-64'}, {'measure': '36-Item Short Form Health Survey (SF-36) score', 'timeFrame': 'At baseline, week 14-26 and week 42-64', 'description': 'SF-36 score at baseline, week 14-26 and week 42-64'}, {'measure': 'EQ-5D score', 'timeFrame': 'At baseline, week 14-26 and week 42-64', 'description': 'EQ-5D score at baseline, week 14-26 and week 42-64'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Through study completion', 'description': 'Incidence of adverse events through study completion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Crohn Disease', 'Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '38926732', 'type': 'DERIVED', 'citation': "Li Q, Huang Z, Yang H, Tang J, Zuo T, Yang Q, Huang Z, Guo Q, Li M, Gao X, Chao K. Intestinal mRNA expression profiles associated with mucosal healing in ustekinumab-treated Crohn's disease patients: bioinformatics analysis and prospective cohort validation. J Transl Med. 2024 Jun 26;22(1):595. doi: 10.1186/s12967-024-05427-w."}]}, 'descriptionModule': {'briefSummary': "Inflammatory bowel disease (IBD) is a chronic immune-related disease, which mainly affects the digestive tract. There are mainly two forms of the disease, including Crohn's disease (CD) and ulcerative colitis (UC).\n\nBiologics have revolutionized the treatment of inflammatory bowel disease with good efficacy and safety. However, 20-50% of patients may not response to or lose response to biologics. Unfortunately, there has been no factors or measures that may predict the efficacy or safety of biologics.\n\nIn this study, a large prospective cohort study is conducted to evaluate the efficacy and safety of biologics (infliximab, adalimumab, vedolizumab, ustekinumab, and other approved biologics) in patients with inflammatory bowel disease in the real clinical practice. Meanwhile, a multi-omics approach involving transcriptomics, microbiome, proteomics, and metabolome, are adopted to explore biomarkers or factors that predict the therapeutic efficacy or safety of biologics. The mechanism underlie the disease will also be explored."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with inflammatory bowel disease treated with approved biologics', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. For patients with IBD:\n\n * Patients with IBD treated with approved biologics\n * Age 18 or over\n * Written informed consent obtained from patient for participation\n2. For non-IBD healthy volunteers:\n\n * Patients without the diagnosis of IBD or other conditions that, in the opinion of the investigator, not suitable to participate in the study\n * Age 18 or over\n * Written informed consent obtained from patient for participation\n\nExclusion Criteria:\n\n* Unable to obtain written informed consent\n* Patient is, in the opinion of the investigator, not suitable to participate in the study'}, 'identificationModule': {'nctId': 'NCT05542459', 'acronym': 'MORE', 'briefTitle': 'Multi-omics to Predict Responses to Biologics in IBD', 'organization': {'class': 'OTHER', 'fullName': 'Sixth Affiliated Hospital, Sun Yat-sen University'}, 'officialTitle': 'Multi-omics to Predict Responses to Biologics in Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': '2022ZSLYEC-136'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-IBD control group', 'description': 'A control group in which patients are not diagnosed as inflammatory bowel disease.'}, {'label': 'CD group', 'description': "A group in which patients are diagnosed as crohn's disease", 'interventionNames': ['Drug: Biologics']}, {'label': 'UC group', 'description': 'A group in which patients are diagnosed as ulcerative colitis', 'interventionNames': ['Drug: Biologics']}], 'interventions': [{'name': 'Biologics', 'type': 'DRUG', 'description': 'Infliximab, adalimumab, vedolizumab, ustekinumab, and other biologics approved for IBD', 'armGroupLabels': ['CD group', 'UC group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongsheng Yang, MD', 'role': 'CONTACT', 'email': 'hensonyang@foxmail.com', 'phone': '+86-20-38663423'}, {'name': 'Xiang Gao, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hongsheng Yang, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Sixth Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Hongsheng Yang, MD', 'role': 'CONTACT', 'email': 'hensonyang@foxmail.com', 'phone': '+86-20-38663423'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sixth Affiliated Hospital, Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Xiang Gao', 'investigatorAffiliation': 'Sixth Affiliated Hospital, Sun Yat-sen University'}}}}