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Role of Inflammation in Progressive Multifocal Leukoencephalopathy (PML)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01132053
Recruitment Status : Completed
First Posted : May 27, 2010
Last Update Posted : February 27, 2019
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Chen Sabrina Tan, Beth Israel Deaconess Medical Center

Brief Summary:
This is a continuation of our previous studies on Progressive Multifocal Leukoencephalopathy (PML). We will focus on the role of inflammation in PML, and define prognostic markers of disease evolution.

Condition or disease
Progressive Multifocal Leukoencephalopathy

Detailed Description:
To determine precisely what are the host or viral factors that may predict a favorable outcome for PML patients and the role of inflammation in preventing JCV from causing brain disease. One of the goals of this study is to help establish non-invasive markers of PML evolution by studying the brain metabolism in PML lesions using Magnetic Resonance Imaging (MRI), Magnetic Spectroscopy (MRS) and other advanced imaging modalities.

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Study Type : Observational
Actual Enrollment : 126 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Role of Inflammation in PML
Actual Study Start Date : June 2004
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

These are subjects who have confirmed PML.
These are subjects who do not have PML. They may be healthy or immune compromised due to Cancer, Transplant, or HIV.

Biospecimen Retention:   Samples With DNA
Blood, Urine, CSF if needed for clinical management.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

PML patients of 18 years of age or older in the Boston area will be included in this study.

The control groups will include HIV+ and HIV- individuals who need to have a lumbar puncture for their clinical management.


Inclusion Criteria:

  • PML patients of 18 years of age or older will be included in this study.

Exclusion Criteria:

  1. Presence of opportunistic brain lesions other than PML. ( e.g., toxoplasmosis, lymphoma)
  2. Presence of confounding neurological disorder such as brain neoplasm etc.

In addition patients with a contraindication to MRI examination will be excluded from study. Contraindications to the MRI examination include:

  1. Medically unstable or hematological, renal, or hepatic dysfunction.
  2. Cardiac pacemaker
  3. Internal clips,
  4. Metal implants, or external clips with 10 mm of the head.
  5. Metal in the eyes.
  6. Pregnant
  7. Claustrophobia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01132053

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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institutes of Health (NIH)
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Principal Investigator: Chen S Tan, MD Beth Israel Deaconess Medical Center
Additional Information:
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Responsible Party: Chen Sabrina Tan, principal investigator, Beth Israel Deaconess Medical Center Identifier: NCT01132053    
Other Study ID Numbers: 2004P000089
NS 047029 ( Other Grant/Funding Number: NIH )
First Posted: May 27, 2010    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Keywords provided by Chen Sabrina Tan, Beth Israel Deaconess Medical Center:
JC Virus
Additional relevant MeSH terms:
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Leukoencephalopathy, Progressive Multifocal
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
Virus Diseases
Polyomavirus Infections
DNA Virus Infections
Slow Virus Diseases
Infectious Encephalitis
Central Nervous System Infections
Demyelinating Diseases