Prospective Cohort Study of Neuromyelitis Optica Spectrum Disorders (NMOSD)

Xiamen Hospital of Traditional Chinese Medicine

Status

Not yet enrolling

Conditions

NMOSD

Treatments

Other: Sex hormone assay

Study type

Observational

Funder types

Other

Identifiers

NCT07266051

2025-K065-01

Details and patient eligibility

About

This study aims to characterize sex hormone alterations and their potential clinical significance in NMOSD patients from Southern China through comprehensive hormonal profiling.

Full 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.

Enrollment

4,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

4,000 participants in 2 patient groups

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.

Treatment:

Other: Sex hormone assay

Healthy control group

Description:

Age- and sex-matched healthy controls (≥18 years) who provided informed consent

Treatment:

Other: Sex hormone assay