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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Immune Checkpoint Inhibitors; Progressive Multifocal Leukoencephalopathy

Treatments: Drug: Immune Checkpoint Inhibitors

Study type: Observational

Funder types: Other

Identifiers

NCT07512518

K23C353

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

66 participants in 2 patient groups

ambidirectional cohort

Description:

an ambidirectional cohort for patients with existing follow-up data

Treatment:

Drug: Immune Checkpoint Inhibitors

prospective cohort

Description:

a prospective cohort for newly diagnosed patients.

Treatment:

Drug: Immune Checkpoint Inhibitors