Evaluating Multiple Sclerosis Patients ShOWing A GEnomic Signature of Therapy Response
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/30/2018 |
| Start Date: | November 7, 2017 |
| End Date: | October 23, 2019 |
To develop a test to characterize and monitor Multiple Sclerosis (MS) disease status and
therapy response from a participant's home by analyzing the gene expression from participant
self-collected blood samples using a novel fingerstick collection kit.
therapy response from a participant's home by analyzing the gene expression from participant
self-collected blood samples using a novel fingerstick collection kit.
Multiple Sclerosis (MS) is an autoimmune disease that damages the central nervous system
(CNS) and disrupts communication to and from the brain by attacking the myelin sheath
surrounding neurons. It impairs control of bodily functions and leads to clinical disability
as the disease progresses. The worldwide population is estimated at 2.5 million. MS typically
develops in young adults; primarily women in their early 30s. The etiology of MS is not fully
understood, but it is noted that the prevalence of MS differs with geography and ethnicity.
Biomarker signature panels are important tools for monitoring treatment response and
screening for individuals who are unlikely to benefit from certain therapies. To establish a
baseline and further characterize gene expression in MS, blood samples from individuals with
MS will be collected. A rapid blood test to predict a treatment response would be an
innovative diagnostic product that could aid in identifying individuals that may benefit from
the targeted therapy. In the long term, such a test could bring significant clinical benefits
by enabling individualized treatment to better control the disease, unburdening healthcare
costs, and dramatically improving the management of MS.
In order to analyze gene expression data from individuals diagnosed with MS, the study will
collect blood samples and information from up to 1500 subjects for analysis.
(CNS) and disrupts communication to and from the brain by attacking the myelin sheath
surrounding neurons. It impairs control of bodily functions and leads to clinical disability
as the disease progresses. The worldwide population is estimated at 2.5 million. MS typically
develops in young adults; primarily women in their early 30s. The etiology of MS is not fully
understood, but it is noted that the prevalence of MS differs with geography and ethnicity.
Biomarker signature panels are important tools for monitoring treatment response and
screening for individuals who are unlikely to benefit from certain therapies. To establish a
baseline and further characterize gene expression in MS, blood samples from individuals with
MS will be collected. A rapid blood test to predict a treatment response would be an
innovative diagnostic product that could aid in identifying individuals that may benefit from
the targeted therapy. In the long term, such a test could bring significant clinical benefits
by enabling individualized treatment to better control the disease, unburdening healthcare
costs, and dramatically improving the management of MS.
In order to analyze gene expression data from individuals diagnosed with MS, the study will
collect blood samples and information from up to 1500 subjects for analysis.
Inclusion Criteria:
- Male and female patients age 18 or older
- Have a permanent address in the United States for the duration of the study
- Have an email address and access to the internet for the duration of the study
- Able to provide informed consent
- Self-reported diagnosis of MS
Exclusion Criteria:
We found this trial at
1
site
Compton, California 90220
Principal Investigator: Robert Terbrueggen, PhD
Phone: 310-537-7857
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