NMOSDNMOSDNCT07266051
Prospective Cohort Study of Neuromyelitis Optica Spectrum Disorders (NMOSD)
An observational study of NMOSD, run by Xiamen Hospital of Traditional Chinese Medicine at 5 sites in China.
Trial summary
This study aims to characterize sex hormone alterations and their potential clinical significance in NMOSD patients from Southern China through comprehensive hormonal profiling. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- NMOSD
- What is being tested?
- Sex hormone assay
- How many people
- 4,000 participants
- Where
- 5 sitesChina
- Study dates
- Dec 2025to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population of NMOSD patients in Southern China
Who may be able to join
- Aged 18 years or older, regardless of sex
- Gender- and age-matched healthy individuals
- Provided informed consent by the participant or their legal guardian
Who cannot join
- 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 locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
The First Affiliated Hospital of Xiamen university
Xiamen, Fujian, 361000
Jianpeng Li, +86 13860192261, 806469536@qq.com
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, Fujian, 361000
Ruiqiang Peng, +86 15880297185, hbprq@163.com
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, 361000
Wei Yiming, +8615652385796, 982210496@qq.com
Zhongshan Hospital (Xiamen), Fudan University
Xiamen, Fujian, 361000
Guoqiang Fei, +86 13681973572, fei.guoqiang@zs-hospital.sh.cn
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361000
Xingyu Chen, +86 136 0090 4488, 2005chenxingyu@163.com
About this study
This study aims to characterize sex hormone alterations and their potential clinical significance in NMOSD patients from Southern China through comprehensive hormonal profiling.
Read the 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.
- Conditions
- NMOSD
- Being tested
- Sex hormone assay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sex hormone assayOther
This study will explore and validate the characteristics of sex hormone levels in MNMOSD
Sex hormone assayOther
This study will explore the comparison of sex hormone levels between a healthy control group and MNMOSD
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Sex hormone assay | |
| Healthy control group | Age- and sex-matched healthy controls (≥18 years) who provided informed consent Receives: Other: Sex hormone assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variations in Serum Sex Hormones
Measured: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionJul 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NMOSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiamen Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Shiyong, Xiamen Hospital of Traditional Chinese Medicine
- Investigators
- Shiyong Li, Study chair, Xiamen Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266051
- Sponsor's protocol ID
- 2025-K065-01
- Acronym
- NMOSD
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Neuromyelitis Optica Spectrum Disorders (NMOSD)
- ClinicalTrials.gov ID
- NCT07266051
- Acronym / sponsor ID
- NMOSD / 2025-K065-01
- Conditions
- NMOSD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Xiamen Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MNOSD patient group | – | Other: Sex hormone assayThe 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 | – | Other: Sex hormone assayAge- and sex-matched healthy controls (≥18 years) who provided informed consent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population of NMOSD patients in Southern China
Key inclusion criteria (3 listed)
- Aged 18 years or older, regardless of sex
- Gender- and age-matched healthy individuals
- Provided informed consent by the participant or their legal guardian
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sex hormone assayThis study will explore and validate the characteristics of sex hormone levels in MNMOSD | Other | MNOSD patient group |
| Sex hormone assayThis study will explore the comparison of sex hormone levels between a healthy control group and MNMOSD | Other | Healthy control group |
Primary outcome
Variations in Serum Sex Hormones
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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Efgartigimod for the Treatment of Acute Optic Neuritis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shiyong Li study chair
Xiamen Hospital of Traditional Chinese Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NMOSD, run by Xiamen Hospital of Traditional Chinese Medicine at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Yiming (+8615652385796, 982210496@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variations in Serum Sex Hormones (time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.