Progressive Multifocal LeukoencephalopathyNCT01132053
Role of Inflammation in Progressive Multifocal Leukoencephalopathy (PML)
An observational study of Progressive Multifocal Leukoencephalopathy, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Progressive Multifocal Leukoencephalopathy
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- PML patients of 18 years of age or older will be included in this study.
Who cannot join
- 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,
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- Metal implants, or external clips with 10 mm of the head.
- Metal in the eyes.
- Pregnant
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: 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.
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.
- Keywords
- JC Virus
- Medical subject headings
- Leukoencephalopathy, Progressive Multifocal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startJun 2004
- Primary completionSep 2016
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Multifocal LeukoencephalopathyStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Chen Sabrina Tan, Beth Israel Deaconess Medical Center
- Investigators
- Chen S Tan, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132053
- Sponsor's protocol ID
- 2004P000089
- Other IDs
- NS 047029
- Status last verified
- Aug 2023
- First submitted
- 26 May 2010
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Inflammation in PML
- ClinicalTrials.gov ID
- NCT01132053
- Acronym / sponsor ID
- 2004P000089
- Keywords
- JC Virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jun 2004 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 27 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- PML patients of 18 years of age or older will be included in this study.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Description of PML studies at BIDMCLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen S Tan, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Progressive Multifocal Leukoencephalopathy, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.