Longitudinal Studies to Identify Biomarkers for Sturge-Weber Syndrome
NCT ID: NCT04717427
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
250 participants
OBSERVATIONAL
2021-09-08
2025-06-30
Brief Summary
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The research aims are:
1. To integrate longitudinal clinical data, radiological data, and blood biomarkers of Sturge-Weber syndrome patients.
2. Identify plasma and imaging biomarkers sensitive to exacerbation of clinical symptoms including seizures, headaches, or stroke-like episodes.
3. For enrolled patients who present with severe neurological symptoms screen blood samples for inflammatory changes.
The target enrollment for this study is about 250 individuals diagnosed with Sturge-Weber Syndrome. The goal of this study is to understand more about Sturge-Weber Syndrome, the possible treatments for this disease, and identify targets for clinical trials. Those participating in the database will be asked to consent to blood draws.
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Detailed Description
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Aim 2: Examine longitudinal Quantitative MRI Baseline MRI datasets will be collected and Limited Data Sets (LDS) will be generated and uploaded to a central imaging database from all participating centers. Subsequent MRI scans will be collected for patients who experience acute exacerbation of clinical symptoms, including seizures, headaches, or stroke-like episodes. Integrated imaging data, detailed treatment data, and detailed clinical data including neurological symptoms, seizures, and headache history will be analyzed.
Aim 3: Collect and Store Blood Samples for Analysis All patients enrolled in BVMC3 study will have blood samples sent to and stored at University of California San Francisco (UCSF). Enrolled patients presenting with stroke-like episodes, stroke, headache, or seizure will have a second blood sample taken at the time of the neurologic symptom and a third sample taken 6 months later, or even later if symptoms have not resolved within 6 months. Multiplex angioma and inflammatory marker array will be assessed on all 3 samples from patients at the same time.
Conditions
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Study Design
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CASE_ONLY
OTHER
Eligibility Criteria
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Inclusion Criteria
* Patients of any age
* Availability of longitudinal clinical and imaging data from all patient EHR records
* Consent to being followed prospectively throughout the course of the study
* Willing to provide blood samples
Exclusion Criteria
* Persons unwilling to sign informed consent
ALL
Yes
Sponsors
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University of California, San Francisco
OTHER
Wayne State University
OTHER
Duke University
OTHER
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Boston Children's Hospital
OTHER
Nationwide Children's Hospital
OTHER
Sturge-Weber Foundation
OTHER
University of Illinois at Chicago
OTHER
Responsible Party
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Jeffrey A Loeb
Professor
Principal Investigators
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Jeffrey Loeb, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago
Locations
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University of California San Francisco
San Francisco, California, United States
University of Illinois At Chicago
Chicago, Illinois, United States
Kennedy Krieger Institute
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
University of New Mexico
Albuquerque, New Mexico, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Jeffrey Loeb, MD, PhD
Role: primary
Other Identifiers
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2020-1165
Identifier Type: -
Identifier Source: org_study_id
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