Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2025-12-27 @ 9:40 PM
Study NCT ID:
NCT04772495
Status:
COMPLETED
Last Update Posted:
2021-02-26
First Post:
2021-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
miRNA Biomarkers in Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035683', 'term': 'MicroRNAs'}], 'ancestors': [{'id': 'D016372', 'term': 'RNA, Antisense'}, {'id': 'D016375', 'term': 'Antisense Elements (Genetics)'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012313', 'term': 'RNA'}, {'id': 'D009696', 'term': 'Nucleic Acids'}, {'id': 'D058727', 'term': 'RNA, Small Untranslated'}, {'id': 'D022661', 'term': 'RNA, Untranslated'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2021-02-23', 'studyFirstSubmitQcDate': '2021-02-23', 'lastUpdatePostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'miRNA expression', 'timeFrame': 'intraoperative', 'description': 'peripheral blood miRNA expressions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple sclerosis', 'miRNA biomarkers', 'peripheral blood molecular diagnostics'], 'conditions': ['Multiple Sclerosis', 'miRNA', 'Epigenetic', 'Biomarker']}, 'descriptionModule': {'briefSummary': 'Multiple Sclerosis (MS) characterized by demyelination and axonal degeneration is a chronic inflammatory disease of the central nervous system (CNS). Recent studies have shown that dysregulated miRNAs alter immune responses, so they may have roles basis on various genetic diseases such as MS and may be potential targets for biomarkers and new therapeutic approaches. In this study, we evaluated the dysregulation of miRNA expression levels at MS and MS stages. We also discussed the potential of these miRNAs to be biomarkers and/or therapeutic targets in MS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients who had been diagnosed with Multiple sclerosis and healthy male and female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The age of 25 years and above\n* at least one Central Nervous System (CNS) demyelination event\n\nExclusion Criteria:\n\n* with genetic diseases, hypertension, head trauma, neuropsychiatric disease, diabetes mellitus, hypertension, cardiac failure, hepatic failure, renal failure, Thalassemia, Sickle cell disease, iron deficiency, and B12 deficiency'}, 'identificationModule': {'nctId': 'NCT04772495', 'briefTitle': 'miRNA Biomarkers in Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Gaziantep'}, 'officialTitle': 'The Potential Candidate miRNA Biomarkers in Multiple Sclerosis', 'orgStudyIdInfo': {'id': '2015/7'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'with Multiple sclerosis', 'interventionNames': ['Genetic: miRNA']}, {'label': 'Control group', 'description': 'not Multiple sclerosis', 'interventionNames': ['Genetic: miRNA']}], 'interventions': [{'name': 'miRNA', 'type': 'GENETIC', 'description': 'miRNA effect on Multiple sclerosis pathology', 'armGroupLabels': ['Control group', 'Study group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Gaziantep', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'Şenay Görücü Yılmaz', 'investigatorAffiliation': 'University of Gaziantep'}}}}