Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-04 @ 4:38 PM
Study NCT ID:
NCT02960958
Status:
UNKNOWN
Last Update Posted:
2018-01-25
First Post:
2016-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolome Analysis in Patients With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2016-11-08', 'studyFirstSubmitQcDate': '2016-11-08', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolic fingerprint of rheumatoid arthritis', 'timeFrame': '1 years', 'description': 'Metabolomic analyses of urine from patients with rheumatoid arthritis, healthy controls and other autoimmune disease'}], 'secondaryOutcomes': [{'measure': 'Correlations between specific metabolites and disease activity/severity of RA', 'timeFrame': '1 year', 'description': 'Identified metabolites and their clinical significances'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rheumatoid arthritis', 'Metabolomics', 'urine'], 'conditions': ['RheumatoId Arthritis']}, 'descriptionModule': {'briefSummary': "The aim of this study is to investigate discriminant metabolites in urine from patients with rheumatoid arthritis (RA) from healthy individuals. Then we determine if the patient's metabolic fingerprint could predict the development or flare-up of RA.", 'detailedDescription': 'Compare metabolites between RA patients and healthy individuals.\n\n1. Collection urine sample\n2. Assessing urine metabolites by 1H NMR spectroscopy\n3. Analyzing the relationships between metabolites and clinical variables'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with rheumatoid arthritis and healthy individuals', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with rheumatoid arthritis meet 2010 American College of Rheumatology/European League against Rheumatism classification criteria.\n\nExclusion Criteria:\n\n* Comorbid with other autoimmune diseases\n* Confirmed with amyloidosis\n* Chronic kidney disease (estimated GFR \\< 60 ml/min/1.73m2)\n* Chronic liver disease\n* Thyroid disease\n* Pregnancy\n* Solid tumor/hematologic malignancy within 5 years'}, 'identificationModule': {'nctId': 'NCT02960958', 'briefTitle': 'Metabolome Analysis in Patients With Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'The Catholic University of Korea'}, 'officialTitle': 'Metabolome Analysis in Patients With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'CiRAD1'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jung Hee Koh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul St.Mary's hospital, The Catholic university of Korea"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jung Hee Koh', 'investigatorAffiliation': 'The Catholic University of Korea'}}}}