Prospective Cohort Study of Neuromyelitis Optica Spectrum Disorders (NMOSD)
NMOSD
1 other identifier
observational
4,000
1 country
5
Brief Summary
This study aims to characterize sex hormone alterations and their potential clinical significance in NMOSD patients from Southern China through comprehensive hormonal profiling.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2025
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2025
CompletedStudy Start
First participant enrolled
December 1, 2025
CompletedFirst Posted
Study publicly available on registry
December 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
December 18, 2025
December 1, 2025
4.6 years
November 18, 2025
December 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Variations in Serum Sex Hormones
Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months.
Study Arms (2)
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.
Healthy control group
Age- and sex-matched healthy controls (≥18 years) who provided informed consent
Interventions
This study will explore and validate the characteristics of sex hormone levels in MNMOSD
Eligibility Criteria
The population of NMOSD patients in Southern China
You may qualify if:
- Aged 18 years or older, regardless of sex
- 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
You may not qualify if:
- Diagnosis of other serious systemic diseases (e.g., malignancy)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
The First Affiliated Hospital of Xiamen university
Xiamen, Fujian, 361000, China
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, Fujian, 361000, China
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, 361000, China
Zhongshan Hospital (Xiamen), Fudan University
Xiamen, Fujian, 361000, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361000, China
Study Officials
- STUDY CHAIR
Shiyong Li
Xiamen Hospital of Traditional Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Xiamen Traditional Chinese Medicine Hospital
Study Record Dates
First Submitted
November 18, 2025
First Posted
December 5, 2025
Study Start
December 1, 2025
Primary Completion (Estimated)
July 1, 2030
Study Completion (Estimated)
December 1, 2030
Last Updated
December 18, 2025
Record last verified: 2025-12