Observational Cohort Study of Chronic Viral Infection in the Central Nervous System (NCT07512518) | Clinical Trial Compass
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 range
14 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Modified Rankin Scale (mRS) Score at 1 Year
Timeframe: 1 year (±3 months) after onset
2
Neuroimaging Findings at 1 Year
Timeframe: 1 year (±3 months) after onset
3
Neuroimaging Findings at 1 Year (±3 months)
Timeframe: 1 year (±3 months) after onset
4
Cerebrospinal Fluid (CSF) Viral Nucleic Acid Detection at 1 Year
Timeframe: 1 year (±3 months) after onset
5
Cerebrospinal Fluid (CSF) Viral Nucleic Acid Detection at 1 Year (±3 months)
. 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.