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

NCT06617962 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2025-10-01

No results posted yet for this study

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.

Conditions

  • Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related Disorders

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.

Sponsors & Collaborators

  • Huashan Hospital

    lead OTHER

Principal Investigators

  • Quan Chao · Huashan Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-18
Primary Completion
2025-06-30
Completion
2025-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06617962 on ClinicalTrials.gov