NMO Spectrum Disorder;Registry StudyNCT03514030
Clinic Registry Study of Optic Neuromyelitis Spectrum Disease in China
An observational study of NMO Spectrum Disorder;Registry Study, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
In 1894, Devic first proposed the concept of neuromyelitis optica(NMO). NMO is an inflammatory demyelinating disease that selectively affects the central nervous system of the optic nerve and spinal cord.In 2004, Lennon and other persons found highly specific AQP4（aquaporin 4）antibodies in NMO patients'sera, and… Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- NMO Spectrum Disorder;Registry Study
- What is being tested?
- serum AQP4-antibody testing method
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who are clinically suspected of being NMOSD
Who may be able to join
- more than 14 years old
- Compliance with the diagnostic standard by the NMO International Diagnostic team in 2015
Who cannot join
- less than 14 years old
- NOT Compliance with the diagnostic standard by the NMO International Diagnostic team in 2015
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tongren Hospital,Capital Medical University
Beijing, Beijing Municipality, 100730
About this study
In 1894, Devic first proposed the concept of neuromyelitis optica(NMO). NMO is an inflammatory demyelinating disease that selectively affects the central nervous system of the optic nerve and spinal cord.In 2004, Lennon and other persons found highly specific AQP4（aquaporin 4）antibodies in NMO patients'sera, and further differentiated between NMO and MS, confirming that NMO is an independent disease.At present, NMO has been widely recognized as an idiopathic and severe demyelinating disease of the central nervous system.In 2015, the international NMO diagnostic team developed the diagnostic criteria based on highly specific AQP4 antibodie.Up to now, in China, there is no data on the number of NMOSD patients, the rate of misdiagnosis, the treatment methods, and the prognosis.This study is committed to build China's NMOSD big data platform to provide the basis for diagnosis, treatment and prognosis of the disease.
- Conditions
- NMO Spectrum Disorder;Registry Study
- Being tested
- serum AQP4-antibody testing method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum AQP4-antibody testing methodDiagnostic test
there are different methods of testing serum AQP4-antibody
| Study group | Role | What they receive |
|---|---|---|
| positive | serum AQP4-antibody is positive Receives: Diagnostic Test: serum AQP4-antibody testing method | |
| negtive | serum AQP4-antibody is negtive Receives: Diagnostic Test: serum AQP4-antibody testing method |
What is being measured
The primary outcome is the main question the study is designed to answer.
misdiagnosis rate
misdiagnosis rate of NMOSD
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start1 Apr 2018
- Primary completionApr 2020 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NMO Spectrum Disorder;Registry StudyStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514030
- Sponsor's protocol ID
- 2018-2
- Status last verified
- Apr 2018
- First submitted
- 20 Apr 2018
- Last updated
- 2 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinic Registry Study of Optic Neuromyelitis Spectrum Disease in China
- ClinicalTrials.gov ID
- NCT03514030
- Acronym / sponsor ID
- 2018-2
- Conditions
- NMO Spectrum Disorder;Registry Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 2 May 2018 (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.
In 1894, Devic first proposed the concept of neuromyelitis optica(NMO). NMO is an inflammatory demyelinating disease that selectively affects the central nervous system of the optic nerve and spinal cord.In 2004, Lennon and other persons found highly specific AQP4（aquaporin 4）antibodies in NMO patients'sera, and further differentiated between NMO and MS, confirming that NMO is an independent disease.At present, NMO has been widely recognized as an idiopathic and severe demyelinating disease of the central nervous system.In 2015, the international NMO diagnostic team developed the diagnostic criteria based on highly specific AQP4 antibodie.Up to now, in China, there is no data on the number of NMOSD patients, the rate of misdiagnosis, the treatment methods, and the prognosis.This study is committed to build China's NMOSD big data platform to provide the basis for diagnosis, treatment and prognosis of the disease.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| positive | – | Diagnostic Test: serum AQP4-antibody testing methodserum AQP4-antibody is positive |
| negtive | – | Diagnostic Test: serum AQP4-antibody testing methodserum AQP4-antibody is negtive |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are clinically suspected of being NMOSD
Key inclusion criteria (2 listed)
- more than 14 years old
- Compliance with the diagnostic standard by the NMO International Diagnostic team in 2015
Key exclusion criteria (2 listed)
- less than 14 years old
- NOT Compliance with the diagnostic standard by the NMO International Diagnostic team in 2015
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 |
|---|---|---|
| serum AQP4-antibody testing methodthere are different methods of testing serum AQP4-antibody | Diagnostic test | negtive, positive |
Primary outcome
misdiagnosis rate
Time frame: 3 years
misdiagnosis rate of NMOSD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Individual participant dataSharing planned: Yes
Related trials for NMO Spectrum Disorder;Registry Study
RecruitingObservational study
Monoclonal Antibody-Based Therapies for AQP4-Positive NMOSD
NMO Spectrum Disorder
RecruitingObservational study
Swiss Pediatric Inflammatory Brain Disease Registry (Swiss-Ped-IBrainD)
Optic Neuritis, Transverse Myelitis
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NMO Spectrum Disorder;Registry Study, run by Beijing Tongren Hospital at 1 site 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
misdiagnosis rate (time frame: 3 years). 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 2 May 2018.