RECRUITING

Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)

Quick Facts

Study Start:2012-11-08
Study Completion:N/A
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01730131

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Suspected or confirmed PML
  2. 2. MRI compatible with PML
  3. 3. Able to participate in the studies and follow-up required by the protocol
  4. 4. At least 2 years old
  1. 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. 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. 3. Pregnancy
  4. 4. Inability to provide informed consent, either directly or via legally authorized representative (LAR)
  5. 5. Unwillingness to consent for collection of biological samples or their cryopreservation

Contacts and Locations

Study Contact

Mauricio A Campillay
CONTACT
(301) 496-3825
mauricio.campillay@nih.gov
Irene CM Cortese, M.D.
CONTACT
(301) 496-1801
corteseir@ninds.nih.gov

Principal Investigator

Irene CM Cortese, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Neurological Disorders and Stroke (NINDS)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

  • Irene CM Cortese, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Neurological Disorders and Stroke (NINDS)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2012-11-08
Study Completion DateN/A

Study Record Updates

Study Start Date2012-11-08
Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

  • Encephalitis
  • Immune Reconstitution Syndrome
  • Human Immunodeficiency Virus
  • Multiple Sclerosis
  • Natural History

Additional Relevant MeSH Terms

  • Progressive Multifocal Leukoencephalopathy