Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-27 @ 9:26 PM
Study NCT ID:
NCT04667650
Status:
COMPLETED
Last Update Posted:
2020-12-16
First Post:
2020-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ocular Mysathenia Gravis Generalization
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-08', 'studyFirstSubmitDate': '2020-12-08', 'studyFirstSubmitQcDate': '2020-12-08', 'lastUpdatePostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to myasthenia gravis generalization', 'timeFrame': '1 year', 'description': 'Kaplan-meier survival estimations, descriptive and multivariate Cox model analyses were computed (age at onset, first year anti-acetylcholine receptor antibody positivity, electromyogram decrement, steroid use).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ocular Myasthenia Gravis']}, 'descriptionModule': {'briefSummary': 'Secondary ocular myasthenia gravis (OMG) generalization represents a pejorative evolution and no validated generalization prevention strategy exists. The aim of this observational study was to determine the percentage of patients with OMG generalization and identify factors predictive of that pejorative evolution. Data from patients with OMG registered in the Fondation Hospital A. de Rothschild database between January 1990 and January 2017 were collected. Among the 183 patients registered in this database, 151 patients with available informations were analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with OMG diagnosis and its generalization who consulted between January 1990 to January 2017 at Fondation Hospital Adolphe de Rothschild and registered in the database', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients with OMG diagnosis and its generalization who consulted between January 1990 to January 2017 at Fondation Hospital Adolphe de Rothschild and registered in the database\n\nExclusion Criteria:\n\n\\- OMG differential diagnoses'}, 'identificationModule': {'nctId': 'NCT04667650', 'acronym': 'MYASTEN', 'briefTitle': 'Ocular Mysathenia Gravis Generalization', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'officialTitle': 'Use of Nomogram for Predictions of Ocular Mysathenia Gravis Generalization', 'orgStudyIdInfo': {'id': 'CE_20161027_22_AGN'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Use of nomogram for predictions of Ocular Mysathenia Gravis generalization', 'type': 'OTHER', 'description': 'The outcome measure was time to Myasthenia gravis generalization. The explanatory variables were age at onset, sex, first-year anti-acetylcholinereceptor antibody positivity, repetiting nerve stimulation showing electromyogram decrement and steroid use. Kaplan-Meier survival estimations, descriptive and multivariate Cox model analyses were computed. A nomogram combining explanatory vraiables was used to establish a score to predict the probability of OMG generalization.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Antoine GUEGUEN', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Amélie Yavchitz', 'investigatorFullName': 'Amélie Yavchitz', 'investigatorAffiliation': 'Fondation Ophtalmologique Adolphe de Rothschild'}}}}