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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Jun 30, 2025 → Dec 31, 2025
See other at-risk trials from Huashan Hospital

Record History

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  1. Primary completion pushed from Jun 30, 2025 to Dec 31, 2025
    • Study completion pushed from Dec 1, 2025 to Dec 31, 2026
    • Eligibility criteria expanded, about 14 words
    • Study description expanded, about 4 words
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 1, 2024 to Nov 18, 2024
    v3
  4. Start date: Sep 15, 2024 to Dec 1, 2024
    • Trial status: Recruiting to Not Yet Recruiting
    • Study sites: 1 to 0
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06617962
Lead Sponsor Huashan Hospital
Conditions
(from sponsor)		 Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related Disorders
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov