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CompletedNCT01132053Updated Aug 14, 2023

Role of Inflammation in Progressive Multifocal Leukoencephalopathy (PML)

An observational study in Progressive Multifocal Leukoencephalopathy, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by Beth Israel Deaconess Medical Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
126
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Progressive Multifocal Leukoencephalopathy

Keywords

  • JC Virus
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In context

Leukoencephalopathy, Progressive Multifocal

29 studies on the registry are indexed under Leukoencephalopathy, Progressive Multifocal; 7 are open to participants now.

This study's enrollment of 126 is above the median of 96 across 12 observational studies indexed under Leukoencephalopathy, Progressive Multifocal.

Browse Leukoencephalopathy, Progressive Multifocal studies →

Lead sponsor

Beth Israel Deaconess Medical Center is the lead sponsor of 568 studies on the registry; 80 are open to participants now.

Of its 76 completed or terminated interventional studies of FDA-regulated products, 62 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
126 participants (actual)
Biospecimen retention
Samples with dna

Groups and 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.

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Study locations

1 site
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01132053
Responsible party
Chen Sabrina Tan (principal investigator, Beth Israel Deaconess Medical Center) — Principal investigator
First posted
May 27, 2010
Start date
Jun 2004
Primary completion
Sep 2016
Completion
Dec 2018
Last update
Aug 14, 2023

Study contacts

Chen S Tan, MD
principal investigator · Beth Israel Deaconess Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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