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RECRUITING
NCT06617962

Evaluation of Two Cell-based Assays for Diagnosing MOG-IgG Associated Disorders

Sponsor: Huashan Hospital

View on ClinicalTrials.gov

Summary

Anti-myelin oligodendrocyte glycoprotein-IgG-associated disorders (MOGAD) is a rare inflammatory autoimmune disease. In addition, since the international MOGAD group proposed live-cell based assays for MOGAD diagnosis in 2023, there are still no real-world cohort validation studies on this methodology. This study intends to establish a large sample cohort with multi-center and paired design. MOG-IgG detection based on live cells and fixed cells was performed on the study participants with high suspicion of MOGAD and the negative control population, to obtain the diagnostic performance parameters and consistency evaluation of the two methodologies, evaluate their clinical diagnostic value, and explore the best individual assay cutoffs for MOG-IgG detection suitable for the diagnosis of MOGAD in China.

Official title: Evaluation of The Diagnostic Value of Two Cell-based Assays for MOG-IgG-associated Diseases: A Multicenter, Paired Design Observational Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

240

Start Date

2024-11-18

Completion Date

2025-12-01

Last Updated

2025-10-01

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

CBA method of live cells and fixed cells

1. Study participants with high clinical suspicion of MOGAD: 2mL serum samples were collected for detection. CBA method of live cells and fixed cells was used for all samples. Sensitivity, specificity, positive predictive value and negative predictive value of the two detection methods were calculated according to the detection results and combined with the 2023 MOGAD diagnostic criteria. 2. Control group:2mL serum samples were collected for detection. CBA method of live cells and fixed cells was used for all samples.

Locations (1)

Huashan Hospital

Shanghai, Shanghai Municipality, China