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Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
2 Years to 120 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 5 visits
  • Procedures mentioned: Physical exams, Urine samples, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Design: * Participants will be screened with a physical exam, medical history, and imaging studies. * Participants will have several visits to the National Institutes of Health Clinical Center."
  • "They will also have neurological tests and imaging studies of the brain. * For the next five visits, participants will give blood and urine samples."
  • "They will also have neurological tests and imaging studies of the brain. * The 6-month and 12-month visits will repeat the tests from the initial visit. * Other optional procedures include bone marrow samples and skin biopsies."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how PML, a serious brain infection caused by JC virus, changes over time. It includes people age 2 or older with PML or at risk for it, and healthy adults. The study does not provide treatment.

Background: \- Progressive multifocal leukoencephalopathy (PML) is a severe viral infection of the brain. It is caused by JC virus. Many people have this virus in their bodies all their life, but it is usually kept in check by their immune system. If the immune system does not work right because of a disease or medication, the virus becomes active and can damage cells in the brain. Not much is known about PML or how it affects the immune system. Researchers want to study people with PML to better understand the natural history of the disease. Objectives: \- To study the natural history of PML. Eligibility: \- Individuals at least 2 years of age who have PML. Design: * Participants will be screened with a physical exam, medical history, and imaging studies. * Participants will have several visits to the National Institutes of Health Clinical Center. There will be an initial visit, monthly visits for the next 6 months, a 12-month visit, and possible visits afterward. * At the initial visit, participants will give blood, urine, and spinal fluid samples. They will also have neurological tests and imaging studies of the brain. * For the next five visits, participants will give blood and urine samples. They will also have neurological tests and imaging studies of the brain. * The 6-month and 12-month visits will repeat the tests from the initial visit. * Other optional procedures include bone marrow samples and skin biopsies. Additional blood tests and imaging studies may be performed. * Treatment will not be provided as part of this study.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Everyone must be able to take part in the study tests and follow-up visits.
  • PML group: Age 2 or older, with suspected or confirmed PML and an MRI brain scan showing signs of PML.
  • At-risk group: Age 2 or older, with a weakened immune system—the body's defense against illness—and a risk of PML.
  • Healthy volunteer group: Age 18 or older.

Who can't join

  • A serious health condition that the study doctor thinks would make the study tests unsafe or impossible.
  • A medical reason you cannot have an MRI scan, such as certain implanted devices or metal in your body, or body piercings that cannot be removed.
  • Pregnancy.
  • Unable to give informed consent, meaning agreement to join after learning about the study, either yourself or through a legally approved representative.
  • Not willing to allow body samples to be collected or frozen for storage.
  • Healthy volunteers only: A weakened immune system, including from certain cancers, long-term diseases that cause swelling, or treatments that weaken or change the immune system.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* 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

Study sites (1)

MD