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Completed

NCT Number: NCT04388072

An Diagnostic Cohort on AQP4-Immunoglobulin G Detection Kit

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.

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Key information

Conditions

Neuromyelitis Optica Spectrum Disorders Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Myelitis, Transverse Nervous System Diseases Neuromyelitis Optica Optic Nerve Diseases Optic Neuritis

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology,First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Collaborators

  • MyBiotech Co. Ltd, China
  • Third Affiliated Hospital, Sun Yat-Sen University

Registry information

Official study title

An Diagnostic Cohort on Applicability and Accuracy of AQP4-Immunoglobulin G Detection Kit in the Diagnosis of Neuromyelitis Optica Spectrum Disorders

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
May 14, 2020
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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