Observational Cohort Study of Chronic Viral Infection in the Central Nervous System

Peking Union Medical College Hospital66 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Progressive Multifocal Leukoencephalopathy Immune Checkpoint Inhibitors

Interventions

Immune Checkpoint InhibitorsDRUG

Immune Checkpoint Inhibitors for PML treatment

Eligibility

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \> 14 years old. 2. Confirmed diagnosis of chronic viral infection of the central nervous system (CNS). 3. 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. Exclusion Criteria: 1. Presence of lumbar puncture contraindications, making it impossible to collect cerebrospinal fluid. 2. The attending physician and the researcher consider that the detection of virus in cerebrospinal fluid cannot explain the patient's clinical manifestations. 3. Inability to complete 1-year follow-up.

Outcomes

Primary Outcomes

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)