Progressive Multifocal LeukoencephalopathyNCT07512518
Observational Cohort Study of Chronic Viral Infection in the Central Nervous System
An observational study of Progressive Multifocal Leukoencephalopathy and Immune Checkpoint Inhibitors, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Progressive Multifocal Leukoencephalopathy, Immune Checkpoint Inhibitors
- What is being tested?
- Immune Checkpoint Inhibitors
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2023to 25 Oct 2030
- How long will I take part?
- 1 Year
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Siyuan Fan, 13426341726, siyuanfan@outlook.com
About this study
Official title: Central Nervous System Chronic Viral Infections: A Cohort Study
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.
- Being tested
- Immune Checkpoint Inhibitors
- Medical subject headings
- Leukoencephalopathy, Progressive Multifocal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Checkpoint InhibitorsDrug
Immune Checkpoint Inhibitors for PML treatment
| Study group | Role | What they receive |
|---|---|---|
| ambidirectional cohort | an ambidirectional cohort for patients with existing follow-up data Receives: Drug: Immune Checkpoint Inhibitors | |
| prospective cohort | a prospective cohort for newly diagnosed patients. Receives: Drug: Immune Checkpoint Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year (±3 months) after onset
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)
Measured: 1 year (±3 months) after onset
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)
Measured: 1 year (±3 months) after onset
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)
Measured: 1 year (±3 months) after onset
Cerebrospinal Fluid (CSF) Viral Nucleic Acid Detection at 1 Year (±3 months)
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)
Measured: 1 year (±3 months) after onset
Secondary outcomes (2)
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)
Measured: 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
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.
Measured: At 1 month after onset, and every 3 months within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start20 Feb 2023
- Primary completion25 Oct 2030 (estimated)
- Study completion25 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Multifocal LeukoencephalopathyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 66 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512518
- Sponsor's protocol ID
- K23C353
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Individual data sharing
- No