Central Nervous System Chronic Viral Infections: A Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Modified Rankin Scale (mRS) Score at 1 Year
研究概览
简要总结
This research team intends to conduct a real-world cohort study of chronic CNS viral infections represented by PML, to evaluate whether administration of immune checkpoint inhibitors improves long-term outcomes in this patient population.Patients with prior follow-up will be enrolled into a retrospective/prospective ambidirectional cohort, and newly diagnosed patients will be enrolled into a prospective cohort.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 14 years old.
- •Confirmed diagnosis of chronic viral infection of the central nervous system (CNS).
- •Signed informed consent. The diagnosis of Progressive Multifocal Leukoencephalopathy (PML) shall meet one of the following criteria:(1) Neuropathological diagnosis: Pathological examination of brain tissue shows demyelination, bizarre astrocytes, and enlarged oligodendroglial nuclei; immunohistochemical detection of JC virus (JCV) antigen.(2) Clinical + imaging + cerebrospinal fluid (CSF) diagnosis: Clinical manifestations of progressive neurological dysfunction; neuroimaging shows single or multiple asymmetric white matter lesions with large volume, mostly involving the U-fibers, and rare mass effect; detection of JC virus DNA in cerebrospinal fluid. Specific reference shall be made to the 2013 American Academy of Neurology (AAN) diagnostic criteria.
- •For the diagnosis of other chronic viral infections of the central nervous system, the clinical manifestations shall be consistent with the characteristics of the relevant diseases, and the relevant viral DNA shall be detected in the cerebrospinal fluid.
- •The diagnosis of all cases must be independently confirmed by two physicians from the Encephalitis Professional Group, Department of Neurology, Peking Union Medical College Hospital, with consistent diagnostic results, to be included in the study. For cases with inconsistent diagnoses, the two physicians shall conduct consultations to reach a consensus. Patients with unreached diagnostic consensus shall not be included in the study.
排除标准
- •Presence of lumbar puncture contraindications, making it impossible to collect cerebrospinal fluid.
- •The attending physician and the researcher consider that the detection of virus in cerebrospinal fluid cannot explain the patient's clinical manifestations.
- •Inability to complete 1-year follow-up.
研究组 & 干预措施
ambidirectional cohort
an ambidirectional cohort for patients with existing follow-up data
干预措施: Immune Checkpoint Inhibitors (Drug)
prospective cohort
a prospective cohort for newly diagnosed patients.
干预措施: Immune Checkpoint Inhibitors (Drug)
结局指标
主要结局
Modified Rankin Scale (mRS) Score at 1 Year
时间窗: 1 year (±3 months) after onset
Assessment of functional disability and neurological recovery using the Modified Rankin Scale at 1 year (±3 months) after onset. Measurement Tool: Modified Rankin Scale (mRS) Unit of Measure: Scale score (0-6; 0 = no symptoms, 6 = death, the higher the worse)
Neuroimaging Findings at 1 Year
时间窗: 1 year (±3 months) after onset
Description: Evaluation of brain structural changes, including the location, extent, and resolution of white matter lesions, using neuroimaging at 1 year (±3 months) after onset. Measurement Tool: Brain Magnetic Resonance Imaging (MRI) Unit of Measure: Qualitative radiological description (e.g., lesion resolution, progression, stability)
Neuroimaging Findings at 1 Year (±3 months)
时间窗: 1 year (±3 months) after onset
Description: Evaluation of brain structural changes, including the location, extent, and resolution of white matter lesions, using neuroimaging at 1 year (±3 months) after onset. Measurement Tool: Brain Magnetic Resonance Imaging (MRI) Unit of Measure: quantitative measurement (e.g., lesion volume in cm³)
Cerebrospinal Fluid (CSF) Viral Nucleic Acid Detection at 1 Year
时间窗: 1 year (±3 months) after onset
Description: Detection of viral nucleic acid (including JC virus and other relevant neurotropic viruses) in cerebrospinal fluid to assess viral clearance or persistence at 1 year (±3 months) after onset. Measurement Tool: Real-time Quantitative Polymerase Chain Reaction (qPCR) Unit of Measure: Qualitative (positive/negative)
Cerebrospinal Fluid (CSF) Viral Nucleic Acid Detection at 1 Year (±3 months)
时间窗: 1 year (±3 months) after onset
Description: Detection of viral nucleic acid (including JC virus and other relevant neurotropic viruses) in cerebrospinal fluid to assess viral clearance or persistence at 1 year (±3 months) after onset. Measurement Tool: Real-time Quantitative Polymerase Chain Reaction (qPCR) Unit of Measure: viral load (copies/mL)
次要结局
- Residual Neurological Symptoms at 1 Month and During Follow-up(At 1 month after onset, and every 3 months within 1 year)
- Modified Rankin Scale (mRS) Score Trends at 1 Month and Every 3 Months Within 1 Year(At 1 month after onset, and every 3 months within 1 year)