Prospective Cohort Study of Neuromyelitis Optica Spectrum Disorders (NMOSD) (NMOSD)

December 11, 2025 updated by: Li Shiyong, Xiamen Hospital of Traditional Chinese Medicine
This study aims to characterize sex hormone alterations and their potential clinical significance in NMOSD patients from Southern China through comprehensive hormonal profiling.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 361000
        • The First Affiliated Hospital of Xiamen University
        • Contact:
      • Xiamen, Fujian, China, 361000
        • Zhongshan Hospital Xiamen University
        • Contact:
      • Xiamen, Fujian, China, 361000
        • The Second Affiliated Hospital of Xiamen Medical College
        • Contact:
          • Ruiqiang Peng
          • Phone Number: +86 15880297185
          • Email: hbprq@163.com
      • Xiamen, Fujian, China, 361000
        • Xiamen Hospital of Traditional Chinese Medicine
        • Contact:
      • Xiamen, Fujian, China, 361000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The population of NMOSD patients in Southern China

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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
Healthy control group
Age- and sex-matched healthy controls (≥18 years) who provided informed consent
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variations in Serum Sex Hormones
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months.
Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiamen Hospital of Traditional Chinese Medicine

Investigators

  • Study Chair: Shiyong Li, Xiamen Hospital of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

December 3, 2025

First Posted (Estimated)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2025-K065-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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