Role of Inflammation in Progressive Multifocal Leukoencephalopathy (PML)

NCT01132053 | Completed

• 2 other identifiers: 2004P000089NS 047029
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Progressive Multifocal Leukoencephalopathy

Keywords

JC Virus

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Presence of opportunistic brain lesions other than PML. ( e.g., toxoplasmosis, lymphoma)
• 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:
• Medically unstable or hematological, renal, or hepatic dysfunction.
• Cardiac pacemaker
• Internal clips,
• Metal implants, or external clips with 10 mm of the head.
• Metal in the eyes.
• Pregnant
• Claustrophobia

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Links

• Description of PML studies at BIDMC

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Urine, CSF if needed for clinical management.

MeSH Terms

Conditions

Leukoencephalopathy, Progressive Multifocal

Condition Hierarchy (Ancestors)

Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Virus Diseases; Polyomavirus Infections; DNA Virus Infections; Slow Virus Diseases; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Leukoencephalopathies; Demyelinating Diseases; Neuroinflammatory Diseases

Study Officials

• Chen S Tan, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 27, 2010
• Study Start: June 1, 2004
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2018
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

US (1)