Observational Cohort Study of Chronic Viral Infection in the Central Nervous System
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14+
SponsorPeking Union Medical College Hospital
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Immune Checkpoint Inhibitors
Treatment groups
66 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov