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Clinical Trials in China / NCT06767020
Active, not recruiting Observational

Comparative Study on AQP4 Antibody Detection Methods

NCT06767020 · tracked via the Priya Life Science China tracker
Sponsor
First Affiliated Hospital of Chongqing Medical University
Phase
Observational
Started
2023-11-11
Last updated
2025-01-09

Condition(s) studied

NMOSD

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
Accepted
Inclusion Criteria: * 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 1. 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, 2. 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 3. 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. Exclusion Criteria: * 1.Patients with incomplete clinical information. 2.Patients without serum samples.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality

More First Affiliated Hospital of Chongqing Medical University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06767020 on ClinicalTrials.gov ↗ ← All trials in China