Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT04386018
Status:
UNKNOWN
Last Update Posted:
2020-11-13
First Post:
2020-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Registered Cohort Study of Inflammatory Demyelination Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}], 'ancestors': [{'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating 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': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-11', 'studyFirstSubmitDate': '2020-05-10', 'studyFirstSubmitQcDate': '2020-05-10', 'lastUpdatePostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The correlation between clinical phenotypes and Serum antibodies', 'timeFrame': 'from date of enrollment until the date of death from any cause,assessed up to 20 years', 'description': 'Different clinical subtypes of Demyelinating Autoimmune Diseases have different course and prognosis.It may be related to different serum antibodies.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Demyelinating Autoimmune Diseases, CNS']}, 'descriptionModule': {'briefSummary': 'This study will provide further insights into the natural course of Inflammatory demyelination disease including clinical features，progression, related antibody spectrum and drug treatment effect'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Inflammatory Demyelination Disease who are diagnosied in the First Affiliated Hospital of Fujian Medical Universtiy by two neurolgists', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Outpatient or inpatient\n2. Meet the diagnostic criteria of Inflammatory Demyelination Disease.\n3. Voluntary participation and informed consent signed by the applicant or his/her family.\n\nExclusion Criteria:\n\n1. Severe complications\n2. Poor prognosis (\\<1 year survival)\n3. Severe mental disorder and inability to cooperate with the examination.'}, 'identificationModule': {'nctId': 'NCT04386018', 'briefTitle': 'A Registered Cohort Study of Inflammatory Demyelination Disease', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Fujian Medical University'}, 'officialTitle': 'A Registered Cohort Study on Natural Course and Drug Efficacy of Inflammatory Demyelination Disease', 'orgStudyIdInfo': {'id': 'MRCTA,ECFAH of FMU [2019]216'}}, 'contactsLocationsModule': {'locations': [{'zip': '350005', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wang Ning, PhD', 'role': 'CONTACT', 'email': 'ningwang@fjmu.edu.cn', 'phone': '86-0591-87982772'}, {'name': 'Aiyu Lin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Neurology,First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'Jin Bi, BA', 'role': 'CONTACT', 'email': '2311306109@qq.com', 'phone': '86-13673527355'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ning Wang, MD., PhD.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Ning Wang, MD., PhD.', 'investigatorAffiliation': 'First Affiliated Hospital of Fujian Medical University'}}}}