NMOSD
Conditions
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.
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
OTHERSex hormone assay
This study will explore and validate the characteristics of sex hormone levels in MNMOSD
Sponsors
Xiamen Hospital of Traditional Chinese Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variations in Serum Sex Hormones | Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months. |
Countries
China
Contacts
Primary ContactWei Yiming
Outcome results
None listed