Understanding the natural history of Progressive Multifocal Leukoencephalopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the natural history and risk factors associated with Progressive Multifocal Leukoencephalopathy (PML), a severe brain infection caused by the JC virus in individuals with compromised immune systems. Participants, aged 2 years and older, will undergo a series of assessments including physical exams, medical history reviews, and imaging studies at the National Institutes of Health Clinical Center. The study will collect clinical data, blood, cerebrospinal fluid, and urine samples over multiple visits to better understand the disease's progression and the immune response to the JC virus. Additionally, a control cohort will be included to compare findings with those at risk for PML.

Why it matters

Who can join: the full rules

* PML Patients

INCLUSION CRITERIA:

1. Suspected or confirmed PML
2. MRI compatible with PML
3. Able to participate in the studies and follow-up required by the protocol
4. At least 2 years old

EXCLUSION CRITERIA:

1. Significant condition, which in the judgment of the principal investigator, would make participation in the diagnostic and research parts of evaluation impossible or risky
2. Medical contraindication to MRI (i.e., devices such as a cardiac pacemaker or infusion pump, other metallic implants, metallic foreign objects, body piercings that cannot be removed)
3. Pregnancy
4. Inability to provide informed consent, either directly or via legally authorized representative (LAR)
5. Unwillingness to consent for collection of biological samples or their cryopreservation

Control Patients at Risk for PML

INCLUSION CRITERIA:

1. Able to participate in the studies and follow-up required by the protocol
2. At least 2 years old
3. Impaired immune function from any cause and considered at risk for PML (i.e.-history of hematological malignancy, chronic inflammatory disease, history of treatment with immune suppressive or immunomodulatory therapies, primary or acquired immunodeficiency syndromes)

EXCLUSION CRITERIA:

1. Significant condition, which in the judgment of the principal investigator, would make participation in the diagnostic and research parts of evaluation impossible or risky
2. Medical contraindication to MRI (i.e., devices such as a cardiac pacemaker or infusion pump, other metallic implants, metallic foreign objects, body piercings that cannot be removed)
3. Pregnancy
4. Inability to provide informed consent, either directly or via legally authorized representative (LAR)
5. Unwillingness to consent for collection of biological samples or their cryopreservation

Healthy Volunteers

INCLUSION CRITERIA:

1. Able to participate in the studies and follow-up required by the protocol
2. At least 18 years old

EXCLUSION CRITERIA:

1. Impaired immune function (i.e.-history of hematological malignancy, chronic inflammatory disease, history of treatment with immune suppressive or immunomodulatory therapies, primary or acquired immunodeficiency syndromes)
2. Significant condition, which in the judgment of the principal investigator, would make participation in the diagnostic and research parts of evaluation impossible or risky
3. Medical contraindication to MRI (i.e., devices such as a cardiac pacemaker or infusion pump, other metallic implants, metallic foreign objects, body piercings that cannot be removed)
4. Pregnancy
5. Inability to provide informed consent, either directly or via legally authorized representative (LAR)
6. Unwillingness to consent for collection of biological samples or their cryopreservation

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Irene CM Cortese, M.D. — National Institute of Neurological Disorders and Stroke (NINDS)
• Study coordinator: Mauricio A Campillay
• Email: mauricio.campillay@nih.gov
• Phone: (301) 496-3825

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using a radioactive tracer to detect immune cells in the brain for multiple sclerosis and PML

  This study is testing a new radioactive tracer to see if it can help find certain immune cells in the brains of people with multiple sclerosis and PML.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.