NMOSDNCT06767020
Comparative Study on AQP4 Antibody Detection Methods
An observational study of NMOSD, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
This study aims to determine which method is more suitable for clinical application by comparing the sensitivity, specificity, and accuracy of serum AQP4-IgG detection using live cell CBA and fixed cell CBA methods, thereby improving the diagnostic accuracy of neuromyelitis optica spectrum disorders (NMOSD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- NMOSD
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2023to 27 Jan 2025
- How long will I take part?
- 120 Days
- 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: Sex, Gender, diagnose, the number of relapses in NMOSD patients
Who may be able to join
- NMOSD: Confirm a diagnosis of NMOSD according to 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis) suspected NMOSD: cases having features suggestive of NMOSD but can not confirm a diagnosis of NMOSD according to 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis).
- the following 'high risk' clinical and laboratory features had to be met
- optic neuritis that was either severe with poor recovery (residual visual acuity in better eye worse or equal to 6/36), bilateral (simultaneous orsequential within 3 months) or recurrent (more than 2 attacks) as the sole clinical manifestation of demyelinating disease,
- severe transverse myelitis with a central cord syndrome (symmetrical, motor, sensory and bladder involvement) and poor recovery (residual EDSS greater than 5.0) or a longitudinally extensive lesion of the spinal cord spanning 3 or more vertebral segments on magnetic resonance imaging (MRI) or
- demyelinating disease clinically confined to the optic nerve and spinal cord with at least one of the following: normal or atypical MRI of the brain (fewer than 2 periventricular lesions), negative oligoclonal bands in cerebrospinal fluid, raised CSF protein or a CSF pleocytosis (more than 10 cells per μl) 2.All subjects provided written informed consent.
Who cannot join
- 1.Patients with incomplete clinical information. 2.Patients without serum samples.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
Official title: A Multi-center Comparative Real-World Study on AQP4 Antibody Detection Methods Using Live Cell and Fixed Cell-Based Assay Technologies
This study aims to determine which method is more suitable for clinical application by comparing the sensitivity, specificity, and accuracy of serum AQP4-IgG detection using live cell CBA and fixed cell CBA methods, thereby improving the diagnostic accuracy of neuromyelitis optica spectrum disorders (NMOSD).
Read the detailed description
This is a multi-center comparative real-world study on AQP4 Antibody Detection Methods Using Live Cell and Fixed Cell-Based Assay Technologies. This study aims to determine which method is more suitable for clinical application by comparing the sensitivity, specificity, and accuracy of serum AQP4-IgG detection using live cell CBA and fixed cell CBA methods, thereby improving the diagnostic accuracy of neuromyelitis optica spectrum disorders (NMOSD). One hundred and twenty patients from 3 centres in China will be enrolled.
- Conditions
- NMOSD
- Keywords
- AQP4, Fixed CBA, Live CBA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NMOSD | cases confirm a diagnosis of NMOSD according to 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis). | |
| suspected NMOSD | cases having features suggestive of NMOSD but can not confirm a diagnosis of NMOSD according to 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis). | |
| MS | cases confirm a diagnosis of MS according to 2017 McDonald criteria with no features suggestive of NMOSD. | |
| Other disease | cases confirm a diagnosis of neurological disease other than NMOSD and MS, including autoimmune encephalitis, viral encephalitis, myasthenia gravis et al. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity (CI%), Specificity (CI%), Accuracy (CI%), PLR (CI%), NLR (CI%)
The sensitivity, 95% confidence interval (CI) for sensitivity, specificity, and 95% CI for specificity of AQP4 antibody detection methods using live cell and fixed cell-based assay technologies in NMOSD and suspected NMOSD, along with the corresponding results from various control groups and overall controls, are given.
Measured: immediately
Secondary outcomes (1)
Agreement ,Cohen's kappa, Spearman correlation coefficient
The agreement ,Cohen's kappa, Spearman correlation coefficient of serum AQP4 antibody detection results using live CBA and fixed CBA.
Measured: immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start11 Nov 2023
- Primary completion27 Jan 2025 (estimated)
- Study completion27 Jan 2025 (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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
- Target duration
- 120 Days
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Jinzhou, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Jinzhou Feng, Ph.D, Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767020
- Sponsor's protocol ID
- AQP4NMO-001
- Status last verified
- Jan 2025
- First submitted
- 4 Jan 2025
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Comparative Real-World Study on AQP4 Antibody Detection Methods Using Live Cell and Fixed Cell-Based Assay Technologies
- ClinicalTrials.gov ID
- NCT06767020
- Acronym / sponsor ID
- AQP4NMO-001
- Conditions
- NMOSD
- Keywords
- AQP4, Fixed CBA, Live CBA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 11 Nov 2023 (actual)
- Primary completion
- 27 Jan 2025 (estimated)
- Study completion
- 27 Jan 2025 (estimated)
- First posted
- 9 Jan 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 determine which method is more suitable for clinical application by comparing the sensitivity, specificity, and accuracy of serum AQP4-IgG detection using live cell CBA and fixed cell CBA methods, thereby improving the diagnostic accuracy of neuromyelitis optica spectrum disorders (NMOSD).
Detailed description
This is a multi-center comparative real-world study on AQP4 Antibody Detection Methods Using Live Cell and Fixed Cell-Based Assay Technologies. This study aims to determine which method is more suitable for clinical application by comparing the sensitivity, specificity, and accuracy of serum AQP4-IgG detection using live cell CBA and fixed cell CBA methods, thereby improving the diagnostic accuracy of neuromyelitis optica spectrum disorders (NMOSD). One hundred and twenty patients from 3 centres in China will be enrolled.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 120 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NMOSD | – | –cases confirm a diagnosis of NMOSD according to 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis). |
| suspected NMOSD | – | –cases having features suggestive of NMOSD but can not confirm a diagnosis of NMOSD according to 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis). |
| MS | – | –cases confirm a diagnosis of MS according to 2017 McDonald criteria with no features suggestive of NMOSD. |
| Other disease | – | –cases confirm a diagnosis of neurological disease other than NMOSD and MS, including autoimmune encephalitis, viral encephalitis, myasthenia gravis et al. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sex, Gender, diagnose, the number of relapses in NMOSD patients
Key inclusion criteria (5 listed)
- NMOSD: Confirm a diagnosis of NMOSD according to 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis) suspected NMOSD: cases having features suggestive of NMOSD but can not confirm a diagnosis of NMOSD according to 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis).
- the following 'high risk' clinical and laboratory features had to be met
- optic neuritis that was either severe with poor recovery (residual visual acuity in better eye worse or equal to 6/36), bilateral (simultaneous orsequential within 3 months) or recurrent (more than 2 attacks) as the sole clinical manifestation of demyelinating disease,
- severe transverse myelitis with a central cord syndrome (symmetrical, motor, sensory and bladder involvement) and poor recovery (residual EDSS greater than 5.0) or a longitudinally extensive lesion of the spinal cord spanning 3 or more vertebral segments on magnetic resonance imaging (MRI) or
- demyelinating disease clinically confined to the optic nerve and spinal cord with at least one of the following: normal or atypical MRI of the brain (fewer than 2 periventricular lesions), negative oligoclonal bands in cerebrospinal fluid, raised CSF protein or a CSF pleocytosis (more than 10 cells per μl) 2.All subjects provided written informed consent.
Key exclusion criteria (1 listed)
- 1.Patients with incomplete clinical information. 2.Patients without serum samples.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity (CI%), Specificity (CI%), Accuracy (CI%), PLR (CI%), NLR (CI%)
Time frame: immediately
The sensitivity, 95% confidence interval (CI) for sensitivity, specificity, and 95% CI for specificity of AQP4 antibody detection methods using live cell and fixed cell-based assay technologies in NMOSD and suspected NMOSD, along with the corresponding results from various control groups and overall controls, are given.
1 secondary outcome
Agreement ,Cohen's kappa, Spearman correlation coefficient
Time frame: immediately
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 9 Jan 2025.
- Individual participant dataSharing planned: No
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A Study to Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, and Pharmacodynamics of Satralizumab in Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)
Neuromyelitis Optica Spectrum Disorder, NMOSD
RecruitingPhase 4
Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD
NMOSD
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.
Jinzhou Feng, Ph.D principal investigator
First Affiliated Hospital of Chongqing Medical University
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 NMOSD, run by First Affiliated Hospital of Chongqing Medical University 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 5 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 9 Jan 2025. 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?
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?
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?
Sensitivity (CI%), Specificity (CI%), Accuracy (CI%), PLR (CI%), NLR (CI%) (time frame: immediately). 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 9 Jan 2025.