NCT07512518 Observational Cohort Study of Chronic Viral Infection in the Central Nervous System
| NCT ID | NCT07512518 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Progressive Multifocal Leukoencephalopathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 66 participants |
| Start Date | 2023-02-20 |
| Primary Completion | 2030-10-25 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
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 manifest