Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-25 @ 6:59 PM
Study NCT ID:
NCT03843658
Status:
UNKNOWN
Last Update Posted:
2019-02-18
First Post:
2019-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identifying Novel Biomarkers in Early Rheumatology Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003095', 'term': 'Collagen Diseases'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2020-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-14', 'studyFirstSubmitDate': '2019-02-14', 'studyFirstSubmitQcDate': '2019-02-14', 'lastUpdatePostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The correlation between novel biomarkers and the primary rheumatology diagnosis', 'timeFrame': '18 month enrollment period. No follow-up period', 'description': "Pearson's correlation coefficient of each biomarker to each cohort"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatologic Disorder']}, 'descriptionModule': {'briefSummary': 'Patients new to a rheumatology practice will be asked if they want to consent to their blood sample, medical records, and hand/foot x-rays (with sharp scores) for the analysis and correlation with the diagnosis they will receive from the rheumatologist.', 'detailedDescription': 'At the end of their first visit new rheumatology patients will be asked for their interest in joining the Inova biomarker study. If yes, the patient will be consented, blood will be drawn for the Inova biomarkers, and x-rays will be sent for sharp scoring. Patients may decline and will not be part of the Inova study. Patients who decline will continue to receive standard of care treatment henceforth.\n\nPatients in the Inova trial will receive a diagnosis from their doctor and are placed into separate cohorts based upon their diagnosis. The Inova biomarker results of each cohort will be cross-correlated with diagnoses, pre-screening tool results. Baseline disease activity and sharp scores will also be correlation variables.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All newly referred adults to Arthritis Northwest PLLC will be offered the opportunity to enroll in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly referred Arthritis Northwest PLLC\n* Age 18 or older\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT03843658', 'briefTitle': 'Identifying Novel Biomarkers in Early Rheumatology Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arthritis Northwest PLLC'}, 'officialTitle': 'Identifying Novel Biomarkers in Early Rheumatology Patients', 'orgStudyIdInfo': {'id': 'R-18002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rheumatoid Arthritis', 'description': 'Clinician diagnosed rheumatoid arthritis', 'interventionNames': ['Other: There is no intervention, but a diagnosis.']}, {'label': 'Spondyloarthropathy', 'description': 'Ankylosing spondylitis and psoriatic arthritis', 'interventionNames': ['Other: There is no intervention, but a diagnosis.']}, {'label': 'Crystalline arthritis', 'description': 'Gout and Pseudo gout', 'interventionNames': ['Other: There is no intervention, but a diagnosis.']}, {'label': 'Connective Tissue Disease', 'description': "Lupus, myositis, scleroderma, and sjogren's", 'interventionNames': ['Other: There is no intervention, but a diagnosis.']}, {'label': 'Non-Inflammatory arthritis', 'description': 'E.g. Osteoarthritis and Fibromyalgia', 'interventionNames': ['Other: There is no intervention, but a diagnosis.']}], 'interventions': [{'name': 'There is no intervention, but a diagnosis.', 'type': 'OTHER', 'description': 'Cohorts will be determined by the primary rheumatology diagnosis.', 'armGroupLabels': ['Connective Tissue Disease', 'Crystalline arthritis', 'Non-Inflammatory arthritis', 'Rheumatoid Arthritis', 'Spondyloarthropathy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Terri Cone', 'role': 'CONTACT', 'email': 'tcone@arthritisnw.com', 'phone': '5098386500'}, {'name': 'Bonnie Burgess', 'role': 'CONTACT', 'email': 'bburgess@arthritisnw.com', 'phone': '5098386500'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arthritis Northwest PLLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Inova Diagnostics Inc', 'class': 'UNKNOWN'}, {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, {'name': 'University of Nebraska', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}