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Recruiting NCT07512518

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

— Observational Progressive Multifocal Leukoencephalopathy Immune Checkpoint Inhibitors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Immune Checkpoint Inhibitors.
Who it may be relevant to
Registry conditions: Progressive Multifocal Leukoencephalopathy, Immune Checkpoint Inhibitors. Basic parameters: from 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Central Nervous System Chronic Viral Infections: A Cohort Study

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.

Interventions

  • Drug Immune Checkpoint Inhibitors
    Immune Checkpoint Inhibitors for PML treatment

Primary outcome measures

  • Modified Rankin Scale (mRS) Score at 1 Year [Time frame: 1 year (±3 months) after onset]
  • Neuroimaging Findings at 1 Year [Time frame: 1 year (±3 months) after onset]
  • Neuroimaging Findings at 1 Year (±3 months) [Time frame: 1 year (±3 months) after onset]
  • Cerebrospinal Fluid (CSF) Viral Nucleic Acid Detection at 1 Year [Time frame: 1 year (±3 months) after onset]
  • Cerebrospinal Fluid (CSF) Viral Nucleic Acid Detection at 1 Year (±3 months) [Time frame: 1 year (±3 months) after onset]
Secondary outcome measures (2)
  • Residual Neurological Symptoms at 1 Month and During Follow-up [Time frame: 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 [Time frame: At 1 month after onset, and every 3 months within 1 year]

Eligibility criteria

Inclusion criteria

  • 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.

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

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT07512518 · K23C353

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗