Prospective Cohort Study of Neuromyelitis Optica Spectrum Disorders (NMOSD)
NCT ID: NCT07266051
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
4000 participants
OBSERVATIONAL
2025-12-31
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MNOSD patient group
The NMOSD patient cohort consisted of adults (≥18 years) who met the 2021 Chinese diagnostic criteria, were AQP4-IgG seropositive, and provided informed consent.
Sex hormone assay
This study will explore and validate the characteristics of sex hormone levels in MNMOSD
Healthy control group
Age- and sex-matched healthy controls (≥18 years) who provided informed consent
Sex hormone assay
This study will explore the comparison of sex hormone levels between a healthy control group and MNMOSD
Interventions
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Sex hormone assay
This study will explore and validate the characteristics of sex hormone levels in MNMOSD
Sex hormone assay
This study will explore the comparison of sex hormone levels between a healthy control group and MNMOSD
Eligibility Criteria
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Inclusion Criteria
* Fulfilled the diagnostic criteria for Neuromyelitis Optica Spectrum Disorders as defined by the 2021 Chinese guidelines for the diagnosis and management of NMOSD
* Seropositive for AQP4-IgG
* Provided informed consent by the participant or their legal guardian
* Aged 18 years or older, regardless of sex
* Gender- and age-matched healthy individuals
* Provided informed consent by the participant or their legal guardian
Exclusion Criteria
* Presence of severe psychiatric disorders that would preclude compliance with study procedures and/or follow-up assessments
* History of infectious pathologies of the central nervous system
* Those with severe liver and kidney function impairment or dysfunction of other vital organs
* Patients with other conditions that do not allow participation in clinical research
* Patients allergic to gadolinium-DPTA
* Patients with other conditions that do not allow participation in clinical research
18 Years
ALL
Yes
Sponsors
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Xiamen Hospital of Traditional Chinese Medicine
OTHER
Responsible Party
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Li Shiyong
Xiamen Traditional Chinese Medicine Hospital
Principal Investigators
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Shiyong Li
Role: STUDY_CHAIR
Xiamen Hospital of Traditional Chinese Medicine
Locations
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The First Affiliated Hospital of Xiamen university
Xiamen, Fujian, China
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, Fujian, China
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, China
Zhongshan Hospital (Xiamen), Fudan University
Xiamen, Fujian, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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Jianpeng Li
Role: primary
Ruiqiang Peng
Role: primary
Wei Yiming
Role: primary
Guoqiang Fei
Role: primary
Xingyu Chen
Role: primary
Other Identifiers
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2025-K065-01
Identifier Type: -
Identifier Source: org_study_id