Observational cohort of chronic brain viral infections (including PML)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This ambidirectional cohort enrolls patients with chronic central nervous system viral infections—retrospectively including those with prior follow-up and prospectively for newly diagnosed cases—and observes outcomes with and without treatment by immune checkpoint inhibitors. PML diagnosis must meet either neuropathological criteria or the clinical/imaging/CSF criteria referenced to the 2013 AAN guidelines. Treatment exposure is recorded observationally rather than via randomization, and investigators will collect clinical, imaging, and CSF data to compare long-term neurological and survival outcomes. The main goal is to determine whether receipt of immune checkpoint inhibitors is associated with improved functional recovery or survival.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Siyuan Fan
• Email: siyuanfan@outlook.com
• Phone: +86 13426341726

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.