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An Diagnostic Cohort on AQP4-Immunoglobulin G Detection Kit

Sponsor
First Affiliated Hospital of Fujian Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT04388072
Collaborator
MyBiotech Co. Ltd, China (Other), Third Affiliated Hospital, Sun Yat-Sen University (Other)
200
Enrollment
2
Locations
9.2
Actual Duration (Months)
100
Patients Per Site
10.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    An Diagnostic Cohort on Applicability and Accuracy of AQP4-Immunoglobulin G Detection Kit in the Diagnosis of Neuromyelitis Optica Spectrum Disorders
    Actual Study Start Date :
    May 15, 2020
    Actual Primary Completion Date :
    Dec 1, 2020
    Actual Study Completion Date :
    Feb 20, 2021

    Outcome Measures

    Primary Outcome Measures

    1. results of AQP4 -immunoglobulin G detection kit [through study completion, an average of 6 months]

      The Serum test results of participants using AQP4 -immunoglobulin G detection kit

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. The patients who were diagnosed with NMOSD , and the cell-based assay was used to determine the AQP4-IgG-seropositive patients;

    2. AQP4-IgG is negative in health people with age and sex matching and determined by cell-based assay;

    3. Female or male, age 14-80;

    4. Patients or authorized family members volunteered to participate in this study and signed informed consent.

    Exclusion Criteria:

    1. Patients with coagulation disorders;

    2. Infection-related encephalitis;

    3. Immune-related encephalitis;

    4. A patient with severe mental illness who cannot cooperate clinically;

    5. A patient with severe jaundice.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Neurology,First Affiliated Hospital of Fujian Medical University Fuzhou Fujian China 350005
    2 Third Affiliated Hospital of Sun Yat-sen University Guangzhou China

    Sponsors and Collaborators

    • First Affiliated Hospital of Fujian Medical University
    • MyBiotech Co. Ltd, China
    • Third Affiliated Hospital, Sun Yat-Sen University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ning Wang, MD., PhD., Director, First Affiliated Hospital of Fujian Medical University
    ClinicalTrials.gov Identifier:
    NCT04388072
    Other Study ID Numbers:
    • LS2019-004-02
    First Posted:
    May 14, 2020
    Last Update Posted:
    Feb 3, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neuromyelitis Optica

    Study Results

    No Results Posted as of Feb 3, 2022