Neuromyelitis Optica Spectrum DisordersNCT04388072
An Diagnostic Cohort on AQP4-Immunoglobulin G Detection Kit
An observational study of Neuromyelitis Optica Spectrum Disorders, run by First Affiliated Hospital of Fujian Medical University at 2 sites in China.
Trial summary
The diagnostic cohort study could will be use to verify the clinical performance of the AQP4 -immunoglobulin G detection kit and whether it has a good correlation with the clinical diagnosis results. The applicability and accuracy of the kit in clinical diagnosis will be verified according to the measured data. Read more about this study
- Who is it for?
- Ages 14 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disorders
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 15 May 2020to 20 Feb 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with NMOSD who are diagnosied in the First Affiliated Hospital of Fujian Medical Universtiy by two neurolgists
Who may be able to join
- The patients who were diagnosed with NMOSD , and the cell-based assay was used to determine the AQP4-IgG-seropositive patients;
- AQP4-IgG is negative in health people with age and sex matching and determined by cell-based assay;
- Female or male, age 14-80;
- Patients or authorized family members volunteered to participate in this study and signed informed consent.
Who cannot join
- Patients with coagulation disorders;
- Infection-related encephalitis;
- Immune-related encephalitis;
- A patient with severe mental illness who cannot cooperate clinically;
- A patient with severe jaundice.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Department of Neurology,First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou
About this study
Official title: An Diagnostic Cohort on Applicability and Accuracy of AQP4-Immunoglobulin G Detection Kit in the Diagnosis of Neuromyelitis Optica Spectrum Disorders
The diagnostic cohort study could will be use to verify the clinical performance of the AQP4 -immunoglobulin G detection kit and whether it has a good correlation with the clinical diagnosis results. The applicability and accuracy of the kit in clinical diagnosis will be verified according to the measured data.
- Conditions
- Neuromyelitis Optica Spectrum Disorders
- Medical subject headings
- Neuromyelitis Optica
What is being measured
The primary outcome is the main question the study is designed to answer.
results of AQP4 -immunoglobulin G detection kit
The Serum test results of participants using AQP4 -immunoglobulin G detection kit
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start15 May 2020
- Primary completion1 Dec 2020
- Study completion20 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis Optica Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- MyBiotech Co. Ltd, China, Third Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Principal investigator, Ning Wang, MD., PhD., First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388072
- Sponsor's protocol ID
- LS2019-004-02
- Status last verified
- Jan 2022
- First submitted
- 10 May 2020
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Diagnostic Cohort on Applicability and Accuracy of AQP4-Immunoglobulin G Detection Kit in the Diagnosis of Neuromyelitis Optica Spectrum Disorders
- ClinicalTrials.gov ID
- NCT04388072
- Acronym / sponsor ID
- LS2019-004-02
- Conditions
- Neuromyelitis Optica Spectrum Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Collaborators
- MyBiotech Co. Ltd, China, Third Affiliated Hospital, Sun Yat-Sen University
- Study start
- 15 May 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 20 Feb 2021 (actual)
- First posted
- 14 May 2020 (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.
The diagnostic cohort study could will be use to verify the clinical performance of the AQP4 -immunoglobulin G detection kit and whether it has a good correlation with the clinical diagnosis results. The applicability and accuracy of the kit in clinical diagnosis will be verified according to the measured data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with NMOSD who are diagnosied in the First Affiliated Hospital of Fujian Medical Universtiy by two neurolgists
Key inclusion criteria (4 listed)
- The patients who were diagnosed with NMOSD , and the cell-based assay was used to determine the AQP4-IgG-seropositive patients;
- AQP4-IgG is negative in health people with age and sex matching and determined by cell-based assay;
- Female or male, age 14-80;
- Patients or authorized family members volunteered to participate in this study and signed informed consent.
Key exclusion criteria (5 listed)
- Patients with coagulation disorders;
- Infection-related encephalitis;
- Immune-related encephalitis;
- A patient with severe mental illness who cannot cooperate clinically;
- A patient with severe jaundice.
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
results of AQP4 -immunoglobulin G detection kit
Time frame: through study completion, an average of 6 months
The Serum test results of participants using AQP4 -immunoglobulin G detection kit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromyelitis Optica Spectrum Disorders, run by First Affiliated Hospital of Fujian Medical University at 2 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
results of AQP4 -immunoglobulin G detection kit (time frame: through study completion, an average of 6 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 3 Feb 2022.