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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ambidirectional cohort | an ambidirectional cohort for patients with existing follow-up data |
| |
| prospective cohort | a prospective cohort for newly diagnosed patients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immune Checkpoint Inhibitors | Drug | Immune Checkpoint Inhibitors for PML treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale (mRS) Score at 1 Year | 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) | 1 year (±3 months) after onset |
| Neuroimaging Findings at 1 Year | 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) | 1 year (±3 months) after onset |
| Neuroimaging Findings at 1 Year (±3 months) | 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) | 1 year (±3 months) after onset |
| Cerebrospinal Fluid (CSF) Viral Nucleic Acid Detection at 1 Year | 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) | 1 year (±3 months) after onset |
| Cerebrospinal Fluid (CSF) Viral Nucleic Acid Detection at 1 Year (±3 months) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Residual Neurological Symptoms at 1 Month and During Follow-up | Documentation of residual neurological symptoms (e.g., motor weakness, sensory disturbance, cognitive impairment) at 1 month after onset, and every 3 months thereafter within 1 year, to assess longitudinal recovery trends. Measurement Way: telephone or outpatient visit conducted by experienced neurologist Unit of Measure: Categorical description of symptoms (newly occurred/presence/absence) |
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Inclusion 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.
Exclusion Criteria:
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The study subjects are patients with chronic viral infections of the central nervous system (CNS), predominantly Progressive Multifocal Leukoencephalopathy (PML).Patients are enrolled consecutively through the neurology encephalitis outpatient department, emergency department, inpatient department, and neurology consultation services.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siyuan Fan | Contact | +86 13426341726 | siyuanfan@outlook.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D007968 | Leukoencephalopathy, Progressive Multifocal |
| ID | Term |
|---|---|
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
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| 1 year (±3 months) after onset |
| 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 | Description: Serial assessment of functional disability using the Modified Rankin Scale at 1 month after onset, and every 3 months thereafter within 1 year, to evaluate longitudinal changes in neurological function. Measurement Tool: Modified Rankin Scale (mRS) obtained by telephone or outpatient visit. Unit of Measure: Scale score (0-6, 0 = no symptoms, 6 = death) at each follow-up time point. | At 1 month after onset, and every 3 months within 1 year |
| D000069544 | Infectious Encephalitis |
| D014777 | Virus Diseases |
| D027601 | Polyomavirus Infections |
| D004266 | DNA Virus Infections |
| D012897 | Slow Virus Diseases |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D056784 | Leukoencephalopathies |
| D003711 | Demyelinating Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |