Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07512518

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Progressive Multifocal Leukoencephalopathy Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases DNA Virus Infections Demyelinating Diseases Encephalitis Encephalitis, Viral Immune Checkpoint Inhibitors Infections Infectious Encephalitis Leukoencephalopathies Leukoencephalopathy, Progressive Multifocal Nervous System Diseases Neuroinflammatory Diseases Polyomavirus Infections Slow Virus Diseases Virus Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location status: Recruiting

Location contact

Siyuan Fan

CONTACT

[email protected]

13426341726

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immune Checkpoint Inhibitors

Drug

Immune Checkpoint Inhibitors for PML treatment

Primary outcomes

  1. Modified Rankin Scale (mRS) Score at 1 Year

    Time frame: 1 year (±3 months) after onset

    Assessment of functional disability and neurological recovery using the Modified Rankin Scale at 1 year (±3 months) after onset.

    Measurement Tool: Modified Rankin Scale (mRS) Unit of Measure: Scale score (0-6; 0 = no symptoms, 6 = death, the higher the worse)

  2. Neuroimaging Findings at 1 Year

    Time frame: 1 year (±3 months) after onset

    Description: Evaluation of brain structural changes, including the location, extent, and resolution of white matter lesions, using neuroimaging at 1 year (±3 months) after onset.

    Measurement Tool: Brain Magnetic Resonance Imaging (MRI) Unit of Measure: Qualitative radiological description (e.g., lesion resolution, progression, stability)

  3. Neuroimaging Findings at 1 Year (±3 months)

    Time frame: 1 year (±3 months) after onset

    Description: Evaluation of brain structural changes, including the location, extent, and resolution of white matter lesions, using neuroimaging at 1 year (±3 months) after onset.

    Measurement Tool: Brain Magnetic Resonance Imaging (MRI) Unit of Measure: quantitative measurement (e.g., lesion volume in cm³)

  4. Cerebrospinal Fluid (CSF) Viral Nucleic Acid Detection at 1 Year

    Time frame: 1 year (±3 months) after onset

    Description: Detection of viral nucleic acid (including JC virus and other relevant neurotropic viruses) in cerebrospinal fluid to assess viral clearance or persistence at 1 year (±3 months) after onset.

    Measurement Tool: Real-time Quantitative Polymerase Chain Reaction (qPCR) Unit of Measure: Qualitative (positive/negative)

  5. Cerebrospinal Fluid (CSF) Viral Nucleic Acid Detection at 1 Year (±3 months)

    Time frame: 1 year (±3 months) after onset

    Description: Detection of viral nucleic acid (including JC virus and other relevant neurotropic viruses) in cerebrospinal fluid to assess viral clearance or persistence at 1 year (±3 months) after onset.

    Measurement Tool: Real-time Quantitative Polymerase Chain Reaction (qPCR) Unit of Measure: viral load (copies/mL)

Secondary outcomes

  1. Residual Neurological Symptoms at 1 Month and During Follow-up

    Time frame: At 1 month after onset, and every 3 months within 1 year

    Documentation of residual neurological symptoms (e.g., motor weakness, sensory disturbance, cognitive impairment) at 1 month after onset, and every 3 months thereafter within 1 year, to assess longitudinal recovery trends.

    Measurement Way: telephone or outpatient visit conducted by experienced neurologist Unit of Measure: Categorical description of symptoms (newly occurred/presence/absence)

  2. 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

    Description: Serial assessment of functional disability using the Modified Rankin Scale at 1 month after onset, and every 3 months thereafter within 1 year, to evaluate longitudinal changes in neurological function.

    Measurement Tool: Modified Rankin Scale (mRS) obtained by telephone or outpatient visit.

    Unit of Measure: Scale score (0-6, 0 = no symptoms, 6 = death) at each follow-up time point.

Study contacts

Contact information is provided by the study sponsor or research team.

Siyuan Fan

CONTACT

[email protected]

+86 13426341726

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Central Nervous System Chronic Viral Infections: A Cohort Study

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.