Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04717427 |
| Other study ID # |
2020-1165 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 8, 2021 |
| Est. completion date |
June 30, 2025 |
Study information
| Verified date |
June 2024 |
| Source |
University of Illinois at Chicago |
| Contact |
Jeffrey Loeb, M.D., Ph.D. |
| Phone |
(312)-996-6496 |
| Email |
jaloeb[@]uic.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Individuals with Sturge-Weber Syndrome (SWS) sometimes have brain involvement which can
result in seizures, stroke-like episodes and neurologic deficits. The purpose of this study
is to integrate longitudinal clinical data, radiological data, and blood biomarkers of
Sturge-Weber syndrome patients.
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.
Description:
Aim 1: Develop a longitudinal database of patients with SWS Clinical sites will collect
longitudinal data retrospectively on measures of clinical symptoms and medications/treatments
for study subjects who participated in the existing BVMC2/SWF registry and consent to
participate in BVMC3 study. Retrospective data will be used to create a longitudinal
dashboard where practitioners can identify predictors of atrisk patients who are most likely
to have a serious neurological symptom and the current treatments. Prospective data
collection: Clinical sites will collect longitudinal data prospectively for at-risk patients
who present with a new, severe neurological symptom.
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.
