Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
Study NCT ID:
NCT03792659
Status:
RECRUITING
Last Update Posted:
2025-11-28
First Post:
2019-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The EXPLORE MG Registry for Myasthenia Gravis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009157', 'term': 'Myasthenia Gravis'}], 'ancestors': [{'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '100 cc (less than 1/2 cup) of blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'targetDuration': '8 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2019-01-02', 'studyFirstSubmitQcDate': '2019-01-02', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of successful blood draws will be reported at the conclusion of the sample collection', 'timeFrame': '8 years', 'description': 'Successful Collection of Blood'}], 'secondaryOutcomes': [{'measure': 'The number of stool samples collected will be reported at the conclusion of the sample', 'timeFrame': '8 years', 'description': 'Count of Stool Samples'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myasthenia Gravis']}, 'referencesModule': {'references': [{'pmid': '32388060', 'type': 'BACKGROUND', 'citation': "Anil R, Kumar A, Alaparthi S, Sharma A, Nye JL, Roy B, O'Connor KC, Nowak RJ. Exploring outcomes and characteristics of myasthenia gravis: Rationale, aims and design of registry - The EXPLORE-MG registry. J Neurol Sci. 2020 Jul 15;414:116830. doi: 10.1016/j.jns.2020.116830. Epub 2020 Apr 16."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to create a Yale University Department of Neurology Myasthenia Gravis (MG) registry that will be used for current and future research projects involving the study of Myasthenia Gravis.', 'detailedDescription': 'This registry will allow for the research of several mechanisms of Myasthenia Gravis (MG) by studying peripheral blood, stool, disease status and course, and treatment of subjects with MG. The EXPLORE-MG Registry focuses on varied aspects of MG such as disease management, health care utilization, health costs, disease characteristics, and diagnostic tools. As such, it will aid in a broader understanding of MG, while providing a registry from which questions about the disease may be better answered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be 18 years of age or older with a clinical diagnosis of a Myasthenia Gravis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients diagnosed with Myasthenia Gravis presenting to the Yale Department of Neurology for clinical care or research interventions will be invited to donate their biological specimens/clinical data.\n\nExclusion Criteria:\n\n* Failure to meet the Inclusion Criteria.'}, 'identificationModule': {'nctId': 'NCT03792659', 'briefTitle': 'The EXPLORE MG Registry for Myasthenia Gravis', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Exploring Outcomes and Characteristics of Myasthenia Gravis: The EXPLORE MG Registry', 'orgStudyIdInfo': {'id': '1602017284'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neurological Outpatients', 'description': "Participants in this group will be recruited from the outpatient clinical population at the Yale University Department of Neurology. Treating physicians will make the initial determination of patients' potential eligibility to participate in the study.", 'interventionNames': ['Other: Blood Sample Draw']}], 'interventions': [{'name': 'Blood Sample Draw', 'type': 'OTHER', 'description': 'Approximately 100 cc (less than 1/2 cup) of blood will be drawn from both groups.', 'armGroupLabels': ['Neurological Outpatients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bailey Munro Sheldon, PhD', 'role': 'CONTACT', 'email': 'bailey.munrosheldon@yale.edu', 'phone': '203-737-7095'}, {'name': 'Richard Nowak, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yale-New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'centralContacts': [{'name': 'Bailey Sheldon, PhD', 'role': 'CONTACT', 'email': 'bailey.munrosheldon@yale.edu', 'phone': '203-737-7095'}], 'overallOfficials': [{'name': 'Richard Nowak, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor, Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}