Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT07266051
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Cohort Study of Neuromyelitis Optica Spectrum Disorders (NMOSD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-12-03', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variations in Serum Sex Hormones', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NMOSD']}, 'descriptionModule': {'briefSummary': 'This study aims to characterize sex hormone alterations and their potential clinical significance in NMOSD patients from Southern China through comprehensive hormonal profiling.', 'detailedDescription': 'This study is a prospective cohort study, aiming to explore the characteristics of sex hormone levels in patients with neuromyelitis optica spectrum disorder (NMOSD). It plans to include 2,000 patients with NMOSD and 2,000 healthy controls, and conduct a 3-year follow-up. By regularly collecting data such as serum sex hormone levels, imaging, neurological function scales, and various biomarkers, the differences between the two groups will be compared and analyzed to reveal the role of sex hormones in NMOSD and their association with disease activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population of NMOSD patients in Southern China', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria Inclusion Criteria for the NMOSD Patient Group\n\n* Aged 18 years or older, regardless of sex\n* Fulfilled the diagnostic criteria for Neuromyelitis Optica Spectrum Disorders as defined by the 2021 Chinese guidelines for the diagnosis and management of NMOSD\n* Seropositive for AQP4-IgG\n* Provided informed consent by the participant or their legal guardian\n\nInclusion Criteria for the Healthy Control Group\n\n* Aged 18 years or older, regardless of sex\n* Gender- and age-matched healthy individuals\n* Provided informed consent by the participant or their legal guardian\n\nExclusion Criteria\n\n* Diagnosis of other serious systemic diseases (e.g., malignancy)\n* Presence of severe psychiatric disorders that would preclude compliance with study procedures and/or follow-up assessments\n* History of infectious pathologies of the central nervous system\n* Those with severe liver and kidney function impairment or dysfunction of other vital organs\n* Patients with other conditions that do not allow participation in clinical research\n* Patients allergic to gadolinium-DPTA\n* Patients with other conditions that do not allow participation in clinical research'}, 'identificationModule': {'nctId': 'NCT07266051', 'acronym': 'NMOSD', 'briefTitle': 'Prospective Cohort Study of Neuromyelitis Optica Spectrum Disorders (NMOSD)', 'organization': {'class': 'OTHER', 'fullName': 'Xiamen Hospital of Traditional Chinese Medicine'}, 'officialTitle': 'Prospective Cohort Study of Neuromyelitis Optica Spectrum Disorders (NMOSD)', 'orgStudyIdInfo': {'id': '2025-K065-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MNOSD patient group', 'description': 'The NMOSD patient cohort consisted of adults (≥18 years) who met the 2021 Chinese diagnostic criteria, were AQP4-IgG seropositive, and provided informed consent.', 'interventionNames': ['Other: Sex hormone assay']}, {'label': 'Healthy control group', 'description': 'Age- and sex-matched healthy controls (≥18 years) who provided informed consent', 'interventionNames': ['Other: Sex hormone assay']}], 'interventions': [{'name': 'Sex hormone assay', 'type': 'OTHER', 'description': 'This study will explore and validate the characteristics of sex hormone levels in MNMOSD', 'armGroupLabels': ['MNOSD patient group']}, {'name': 'Sex hormone assay', 'type': 'OTHER', 'description': 'This study will explore the comparison of sex hormone levels between a healthy control group and MNMOSD', 'armGroupLabels': ['Healthy control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '361000', 'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'contacts': [{'name': 'Jianpeng Li', 'role': 'CONTACT', 'email': '806469536@qq.com', 'phone': '+86 13860192261'}], 'facility': 'The First Affiliated Hospital of Xiamen university', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '361000', 'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'contacts': [{'name': 'Ruiqiang Peng', 'role': 'CONTACT', 'email': 'hbprq@163.com', 'phone': '+86 15880297185'}], 'facility': 'The Second Affiliated Hospital of Xiamen Medical College', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '361000', 'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'contacts': [{'name': 'Wei Yiming', 'role': 'CONTACT', 'email': '982210496@qq.com', 'phone': '+8615652385796'}], 'facility': 'Xiamen Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '361000', 'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'contacts': [{'name': 'Guoqiang Fei', 'role': 'CONTACT', 'email': 'fei.guoqiang@zs-hospital.sh.cn', 'phone': '+86 13681973572'}], 'facility': 'Zhongshan Hospital (Xiamen), Fudan University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '361000', 'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'contacts': [{'name': 'Xingyu Chen', 'role': 'CONTACT', 'email': '2005chenxingyu@163.com', 'phone': '+86 136 0090 4488'}], 'facility': 'Zhongshan Hospital Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}], 'centralContacts': [{'name': 'Wei Yiming', 'role': 'CONTACT', 'email': '982210496@qq.com', 'phone': '+8615652385796'}], 'overallOfficials': [{'name': 'Shiyong Li', 'role': 'STUDY_CHAIR', 'affiliation': 'Xiamen Hospital of Traditional Chinese Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiamen Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Xiamen Traditional Chinese Medicine Hospital', 'investigatorFullName': 'Li Shiyong', 'investigatorAffiliation': 'Xiamen Hospital of Traditional Chinese Medicine'}}}}