Role of Inflammation in Progressive Multifocal Leukoencephalopathy (PML)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01132053
First received: May 26, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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
Progressive Multifocal Leukoencephalopathy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Role of Inflammation in PML

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Biospecimen Retention:   Samples With DNA

Blood, Urine, CSF if needed for clinical management.


Estimated Enrollment: 180
Study Start Date: June 2004
Estimated Study Completion Date: September 2013
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01132053

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Igor J Koralnik, MD Beth Israel Deaconess Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Igor Koralnik MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01132053     History of Changes
Other Study ID Numbers: 2004-P-000089, NS 047029
Study First Received: May 26, 2010
Last Updated: May 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
JCV

Additional relevant MeSH terms:
Inflammation
Leukoencephalopathy, Progressive Multifocal
Leukoencephalopathies
Pathologic Processes
Encephalitis, Viral
Encephalitis
Central Nervous System Viral Diseases
Virus Diseases
Polyomavirus Infections
DNA Virus Infections
Slow Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Demyelinating Diseases

ClinicalTrials.gov processed this record on August 20, 2014