RecruitingNot Applicable

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

China66 participantsStarted 2023-02-20

Plain-language summary

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.

Who can participate

Age range14 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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.

What they're measuring

Modified Rankin Scale (mRS) Score at 1 Year

Timeframe: 1 year (±3 months) after onset

Neuroimaging Findings at 1 Year

Timeframe: 1 year (±3 months) after onset

Neuroimaging Findings at 1 Year (±3 months)

Timeframe: 1 year (±3 months) after onset

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

Timeframe: 1 year (±3 months) after onset

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

Timeframe: 1 year (±3 months) after onset

Trial details

NCT IDNCT07512518

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-10-25

Contact for this trial

Siyuan Fan

+86 13426341726 siyuanfan@outlook.com

View on ClinicalTrials.gov More Progressive Multifocal Leukoencephalopathy trials

Plain-language summary

Who can participate

Age range14 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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.

What they're measuring

Modified Rankin Scale (mRS) Score at 1 Year

Timeframe: 1 year (±3 months) after onset

Neuroimaging Findings at 1 Year

Timeframe: 1 year (±3 months) after onset

Neuroimaging Findings at 1 Year (±3 months)

Timeframe: 1 year (±3 months) after onset

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

Timeframe: 1 year (±3 months) after onset

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

Timeframe: 1 year (±3 months) after onset