Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT04674605
Status:
UNKNOWN
Last Update Posted:
2020-12-19
First Post:
2020-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Cohort Study Of 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-16', 'studyFirstSubmitDate': '2020-12-14', 'studyFirstSubmitQcDate': '2020-12-16', 'lastUpdatePostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myasthenia gravis foundation of America post intervention status', 'timeFrame': '3 years', 'description': 'Complete Stable Remission (CSR) Pharmacologic Remission (PR) Minimal Manifestations (MM) Change in Status: Improved (I) Unchanged (U) Worse (W) Exacerbation (E) Died of MG (D of MG)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myasthenia Gravis', 'Prognostic prediction'], 'conditions': ['Myasthenia Gravis', 'Myasthenia Gravis Crisis']}, 'descriptionModule': {'briefSummary': 'The average annual incidence of Myasthenia gravis is up to (8.0-20.0) / 100,000 people. Myasthenia gravis is an acquired autoimmune disease. All skeletal muscles of patients may be involved. When ocular muscles are involved, ptosis, diplopia and other symptoms may occur. When the laryngopharyngeal muscles are involved, the patient may develop dysarthria, dysphagia and other symptoms. However, when the respiratory muscles are involved, patients will have difficulty in breathing, and some patients may develope myasthenia crisis, and artificial assisted respiratory therapy is often needed.\n\nThis study is a prospective observational study, in which patients are continuously enrolled, basic information of patients is collected, and biological samples are collected. The purpose of this study is to improve the diagnosis and prognosis of myasthenia gravis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Chinese', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meeting the diagnosis of myasthenia gravis\n\nExclusion Criteria:\n\n* Malignant tumor or other serious chronic disease'}, 'identificationModule': {'nctId': 'NCT04674605', 'briefTitle': 'A Prospective Cohort Study Of Myasthenia Gravis', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'A Prospective Cohort Study Of Myasthenia Gravis', 'orgStudyIdInfo': {'id': '2020-382'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ocular myasthenia gravis', 'interventionNames': ['Device: biomarkers']}, {'label': 'generalized myasthenia gravis', 'interventionNames': ['Device: biomarkers']}], 'interventions': [{'name': 'biomarkers', 'type': 'DEVICE', 'description': 'biomarkers', 'armGroupLabels': ['generalized myasthenia gravis', 'ocular myasthenia gravis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fei Xiao, MD', 'role': 'CONTACT', 'email': 'feixiao81@126.com'}], 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '400016', 'city': 'Chongqing', 'state': 'YuZhong District', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fei Xiao, MD', 'role': 'CONTACT', 'email': 'feixiao86@126.com'}], 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Fei Xiao, MD', 'role': 'CONTACT', 'email': 'feixiao81@126.com', 'phone': '86 23 89012009'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.Fei Xiao', 'investigatorFullName': 'Fei Xiao', 'investigatorAffiliation': 'First Affiliated Hospital of Chongqing Medical University'}}}}