Evaluation of The Diagnostic Value of Two Cell-based Assays for MOG-IgG-associated Diseases: A Multicenter, Paired Design Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- diagnostic performance parameters and consistency evaluation
研究概览
简要总结
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.
详细描述
Study design: A multicenter, observational study to compare the diagnosis performance of two cell-based assays in Chinese patients with idiopathic demyelinating disorders Participants: In this study, serum samples were collected from participants with high clinical suspicion of MOGAD (the number of valid positive cases was 150), and control samples were collected (including 30 participants in other inflammatory CNS disease studies, 30 participants in non-inflammatory CNS studies, and 30 participants in healthy people studies).
Aim: In this multicenter study, a cell-based assay (CBA) based on cell transfection was proposed to semi-quantitatively detect specific antibodies in human serum samples of study participants with highly suspected clinical manifestations of MOGAD and the control population. Each study participant used two CBA detection methods to detect MOG-IgG at the same time, namely live cell based and fixed cell based, to obtain diagnostic performance parameters and consistency evaluation (sensitivity, specificity, positive predictive value, negative predictive value) of the two methods, and combined with comprehensive clinical diagnosis to compare their clinical diagnostic value. To explore the individual assay cutoffs for the diagnosis of MOGAD in China.
Total enrollment: participants with high clinical suspicion of MOGAD (the number of valid positive cases was 150), and control samples were collected (including 30 participants in other inflammatory CNS disease studies, 30 participants in non-inflammatory CNS studies, and 30 participants in healthy people studies).
Time frame: August 1, 2024 to December 1, 2025.
Study protocol:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
diagnostic performance parameters and consistency evaluation
时间窗: August 1, 2024 to December 1, 2025.
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.
次要结局
未报告次要终点