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

Официальное название

Central Nervous System Chronic Viral Infections: A Cohort Study

Обзор

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.

Вмешательства

• Препарат Immune Checkpoint Inhibitors
  Immune Checkpoint Inhibitors for PML treatment

Первичные конечные точки

• Modified Rankin Scale (mRS) Score at 1 Year [Срок оценки: 1 year (±3 months) after onset]
• Neuroimaging Findings at 1 Year [Срок оценки: 1 year (±3 months) after onset]
• Neuroimaging Findings at 1 Year (±3 months) [Срок оценки: 1 year (±3 months) after onset]
• Cerebrospinal Fluid (CSF) Viral Nucleic Acid Detection at 1 Year [Срок оценки: 1 year (±3 months) after onset]
• Cerebrospinal Fluid (CSF) Viral Nucleic Acid Detection at 1 Year (±3 months) [Срок оценки: 1 year (±3 months) after onset]

Вторичные конечные точки (2)

• Residual Neurological Symptoms at 1 Month and During Follow-up [Срок оценки: 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 [Срок оценки: At 1 month after onset, and every 3 months within 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Peking Union Medical College Hospital — Пекин

Идентификаторы

NCT: NCT07512518 · K23C353

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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