Prospective Cohort Study of Neuromyelitis Optica Spectrum Disorders (NMOSD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sex hormone assay, Sex hormone assay.
- Who it may be relevant to
- Registry conditions: NMOSD. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study aims to characterize sex hormone alterations and their potential clinical significance in NMOSD patients from Southern China through comprehensive hormonal profiling.
Detailed description
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.
Interventions
- Other Sex hormone assay
This study will explore and validate the characteristics of sex hormone levels in MNMOSD - Other Sex hormone assay
This study will explore the comparison of sex hormone levels between a healthy control group and MNMOSD
Primary outcome measures
- Variations in Serum Sex Hormones [Time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months.]
Eligibility criteria
Inclusion Criteria Inclusion Criteria for the NMOSD Patient Group
- 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
Inclusion Criteria for the Healthy Control Group
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 5 centers
- The First Affiliated Hospital of Xiamen university — Xiamen
- The Second Affiliated Hospital of Xiamen Medical College — Xiamen
- Xiamen Hospital of Traditional Chinese Medicine — Xiamen
- Zhongshan Hospital (Xiamen), Fudan University — Xiamen
- Zhongshan Hospital Xiamen University — Xiamen
Identifiers
NCT: NCT07266051 · 2025-K065-01