Status:

COMPLETED

An Diagnostic Cohort on AQP4-Immunoglobulin G Detection Kit

Lead Sponsor:

First Affiliated Hospital of Fujian Medical University

Collaborating Sponsors:

MyBiotech Co. Ltd, China

Third Affiliated Hospital, Sun Yat-Sen University

Conditions:

Neuromyelitis Optica Spectrum Disorders

Eligibility:

All Genders

14-80 years

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. ...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

May 15 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 20 2021

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT04388072

Start Date

May 15 2020

End Date

February 20 2021

Last Update

February 3 2022

Active Locations (2)

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Page 1 of 1 (2 locations)

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