Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)

What this Trial Is About

Progressive multifocal leukoencephalopathy (PML) is a serious brain infection caused by the reactivation of the JC virus, which usually remains controlled by a healthy immune system. This research aims to better understand how PML develops and progresses, especially in people with weakened immune systems from various conditions or treatments. The study also includes patients at risk for PML and healthy volunteers to explore potential biomarkers for early diagnosis and risk assessment. Participants include those with suspected or confirmed PML, individuals with impaired immune function at risk for PML, and healthy volunteers. Participants will undergo detailed clinical, imaging, and laboratory assessments over time. Visits include an initial evaluation, monthly visits for six months, a 12-month visit, and possible follow-up visits. Samples such as blood, urine, cerebrospinal fluid, and optional bone marrow and skin biopsies will be collected. No treatments are provided as part of the study. During the study, participants will undergo neurological tests, brain imaging, and sample collection to monitor disease features and immune responses. Researchers will analyze clinical, radiological, immunological, genetic, and viral data to characterize disease presentation and progression. The study aims to develop a disease-specific assessment scale for PML and create a repository of biological samples for future research. Participation may last more than a year with scheduled follow-ups.

Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)