Comparative Study on AQP4 Antibody Detection Methods

NCT ID: NCT06767020

Last Updated: 2025-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-11

Study Completion Date

2025-01-27

Brief Summary

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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).

Detailed Description

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This is a multi-center comparative real-world study on AQP4 Antibody Detection Methods Using Live Cell and Fixed Cell-Based Assay Technologies. 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). One hundred and twenty patients from 3 centres in China will be enrolled.

Conditions

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NMOSD

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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NMOSD

cases confirm a diagnosis of NMOSD according to 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis).

No interventions assigned to this group

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).

No interventions assigned to this group

MS

cases confirm a diagnosis of MS according to 2017 McDonald criteria with no features suggestive of NMOSD.

No interventions assigned to this group

Other disease

cases confirm a diagnosis of neurological disease other than NMOSD and MS, including autoimmune encephalitis, viral encephalitis, myasthenia gravis et al.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Feng Jinzhou

Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jinzhou Feng, Ph.D

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Chongqing Medical University

Locations

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First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

Other Identifiers

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AQP4NMO-001

Identifier Type: -

Identifier Source: org_study_id

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