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
This trial does not accept healthy volunteersQualifiers
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 population
The study subjects are patients with chronic viral infections of the central nervous system (CNS), predominantly Progressive Multifocal Leukoencephalopathy (PML).Patients are enrolled consecutively through the neurology encephalitis outpatient department, emergency department, inpatient department, and neurology consultation services.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Immune Checkpoint Inhibitors
DrugImmune Checkpoint Inhibitors for PML treatment
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: ambidirectional cohort1 intervention
Group B: prospective cohort1 intervention
Trial outcomes
Primary outcomes
1
Modified Rankin Scale (mRS) Score at 1 Year
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)
Time frame
1 year (±3 months) after onset2
Neuroimaging Findings at 1 Year
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)
Time frame
1 year (±3 months) after onset3
Neuroimaging Findings at 1 Year (±3 months)
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)
Time frame
1 year (±3 months) after onset4
Cerebrospinal Fluid (CSF) Viral Nucleic Acid Detection at 1 Year
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)
Time frame
1 year (±3 months) after onsetSecondary outcomes
1
Residual Neurological Symptoms at 1 Month and During Follow-up
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)
Time frame
At 1 month after onset, and every 3 months within 1 year2
Modified Rankin Scale (mRS) Score Trends at 1 Month 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.
Time frame
At 1 month after onset, and every 3 months within 1 yearSponsors and contacts
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Source ClinicalTrials.gov