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

NCT06617962 | Recruiting

• 1 other identifier: KY2024-1005
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• diagnostic performance parameters and consistency evaluation

  Each study participant used two cell-based assays to detect MOG-IgG simultaneously, namely live cell based and fixed cell based, to obtain the diagnostic performance parameters and consistency evaluation (sensitivity, specificity, positive predictive value, negative predictive value) of the two methodologies.

  August 1, 2024 to December 1, 2025.

Study Arms (2)

Study participants with high clinical suspicion of MOGAD

Based on the "Chinese Expert Consensus on the Diagnosis and Treatment of Myelin Oligodendrocyte Glycoprotein Immunoglobulin MOG-IgG Antibody Associated Diseases" and the "Diagnosis of myelin oligodendrocyte glycoprotein antibody-associated disease: International MOGAD Panel proposed criteria" in2023

Diagnostic Test: CBA method of live cells and fixed cells

Control group

including 30 participants in the study of other inflammatory CNS diseases, 30 participants in the study of non-inflammatory CNS and 30 participants in the study of healthy people

Diagnostic Test: CBA method of live cells and fixed cells

Interventions

CBA method of live cells and fixed cells DIAGNOSTIC_TEST

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.

Control group; Study participants with high clinical suspicion of MOGAD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individual medical units plan to collect serum samples from clinically suspected MOGAD study participants (150 valid positive cases will be the cutoff for sample collection) between September 2024 and December 2024.

You may qualify if:

• age ≥18 years old, male and female.
• MOGAD is highly suspected.
• Other inflammatory CNS disease control groups include: According to the diagnostic criteria and consensus of various diseases, the diagnosis of multiple sclerosis, Autoimmune encephalitis (except NMDAR encephalitis), Guillain-Barre syndrome (GBS), Chronic Inflammatory Demyelinating polyradiculopathy (CIDP), Retinal Cerebrovascular disease (SUSAC), POEMS syndrome (POEMS), and neuropathy were confirmed. The monoclonal gammopathy of unknown significance (MGUS), Sarcoidosis and so on.
• The control group of non-inflammatory central nervous system diseases included: Migraine, CSVD, benign cranial hypertension, Glioma with definite diagnosis and no other autoimmune diseases.
• Healthy controls include healthy people who have no autoimmune diseases through physical examination and other means.
• Complete clinical data.
• Informed consent of the patient or his guardian has been obtained.

You may not qualify if:

• According to the Guidelines for Diagnosis and Treatment of Optic Neuromyelitis Spectrum Diseases (2021), patients with optic Neuromyelitis Spectrum diseases (NMOSD) with positive AQP4 were clearly diagnosed.
• According to the Expert Consensus on the Diagnosis and Treatment of Autoimmune encephalitis in China (2022), the diagnosis was confirmed as NMDAR encephalitis.
• Patients with positive anti-glial fibrillary acidic protein antibody (GFAP-IgG) in serum and/or cerebrospinal fluid.
• Lack of clinical data.
• Unqualified blood samples.
• The patient\'s informed consent was not obtained.
• Misdiagnosis in the research process went wrong in this study.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

Study Officials

• Quan Chao

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Quan

CONTACT

86 13651957283; chao_quan@fudan.edu.cn

Jingzi Zhangbao

CONTACT

86 13661682637; zhangbaojingzi@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 1, 2024
• Study Start: November 18, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 1, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-08

Locations

CN (1)