Role of Inflammation in Progressive Multifocal Leukoencephalopathy (PML)

August 9, 2023 updated by: Chen Sabrina Tan, Beth Israel Deaconess Medical Center

Role of Inflammation in PML

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Chen S Tan, MD, Beth Israel Deaconess Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

June 1, 2004

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

May 26, 2010

First Submitted That Met QC Criteria

May 26, 2010

First Posted (Estimated)

May 27, 2010

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004P000089
  • NS 047029 (Other Grant/Funding Number: NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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