Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2026-01-01 @ 1:44 AM
Study NCT ID:
NCT04292834
Status:
UNKNOWN
Last Update Posted:
2021-12-30
First Post:
2020-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Registered Cohort Study of Immune-Mediated Neuropathies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020277', 'term': 'Polyradiculoneuropathy, Chronic Inflammatory Demyelinating'}], 'ancestors': [{'id': 'D011129', 'term': 'Polyradiculoneuropathy'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2025-01-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-28', 'studyFirstSubmitDate': '2020-02-28', 'studyFirstSubmitQcDate': '2020-02-28', 'lastUpdatePostDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-19', '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 GBS and CIDP have different course and prognosis.It may be related to different serum antibodies.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Inflammatory Demyelinating Polyneuropathy']}, 'descriptionModule': {'briefSummary': 'This study will provide further insights into the natural course of the disease about Immune-Mediated Neuropathies including clinical features，progression, related antibody spectrum and drug treatment effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with GBS,CIDP,MMN who are diagnosied in the First Affiliated Hospital of Fujian Medical Universtiy and Beijing Tiantan Hospital, Capital Medical University by two neurolgists', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- 1. Outpatient or inpatient 2. Meet the diagnostic criteria of various inflammatory peripheral neuropathy. 3. Voluntary participation and informed consent signed by the applicant or his/her family.\n\n4\\. Age 18 or above\n\nExclusion Criteria:\n\n1. Severe complications\n2. Poor prognosis (\\<1 year survival)\n3. Severe mental disorder and inability to cooperate with the examination.\n4. Age less than 18'}, 'identificationModule': {'nctId': 'NCT04292834', 'briefTitle': 'A Registered Cohort Study of Immune-Mediated Neuropathies', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Fujian Medical University'}, 'officialTitle': 'A Registered Cohort Study of Immune-Mediated Neuropathies', 'orgStudyIdInfo': {'id': 'MRCTA，ECFAH of FMU2019217'}}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zaiqiang Zhang', 'role': 'CONTACT'}, {'name': 'Zaiqiang Zhang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Tiantan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '350005', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wang Ning, PhD', 'role': 'CONTACT', 'email': 'ningwang@fjmu.edu.cn', 'phone': '86-0591-87982772'}, {'name': 'Wang MD Ning, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Neurology,First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'Lin Yi, PhD', 'role': 'CONTACT', 'email': 'linyi7811@163.edu', 'phone': '86-0591-87982772'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Fujian Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Ning Wang, MD., PhD.', 'investigatorAffiliation': 'First Affiliated Hospital of Fujian Medical University'}}}}