Gene Expression Profiles in Multiple Sclerosis (MS)



Status:Active, not recruiting
Conditions:Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 70
Updated:7/20/2018
Start Date:March 2006
End Date:August 2027

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Gene Expression Profiles in Patients With Multiple Sclerosis

The purpose of this study is to test differences in RNA levels between Multiple Sclerosis
(MS) patients and normal subjects. RNA provides a "message" from genes altered in diseases.
We will also test DNA to determine if there are any small mutations called SNPs in any of the
genes. The last tests are two separate tests for markers of inflammation called cytokines and
eicosanoids. This research may lead to the discovery of biological markers for MS that are
useful for diagnosis and treatment.

This is an investigator-initiated, pilot study of gene expression (RNA) in the blood of
patients with multiple sclerosis (MS). The study will enroll patients from the UC Davis
Multiple Sclerosis clinic. At a single study visit, we will confirm eligibility, obtain
clinical information, and collect blood samples. We will then process these samples to obtain
RNA for subsequent microarray analysis. DNA will also be used to examine single nucleotide
polymorphisms (SNPs) on chips that allow us to examine 1 million of these SNPs. The SNPs may
allow us to diagnose a disease like multiple sclerosis or to predict a treatment or cause. In
addition, the DNA may be used to determine if there are any small mutations in any of the
genes in the individuals who donate their blood. Additional studies will be done on blood
plasma, testing for inflammatory molecules called eicosanoids and cytokines. The data from
these tests will be superimposed on the microarray data to determine a molecular profile for
each patient. We will then compare the data obtained between patient groups to determine gene
alterations specific for each condition.

Inclusion Criteria:

- males and females

- any race

- Between the ages of 18 and 70 years

- Diagnosed with a clinically isolated syndrome or the diagnosis of multiple sclerosis
using the widely established Macdonald criteria. A 'clinically isolated syndrome'
refers to an isolated attack of optic neuritis, transverse myelitis, or brain
demyelination. Relapsing-remitting MS is characterized by acute relapses that are
followed by some degree of recovery without worsening of disability between relapses.
Chronic progressive MS is defined as sustained progression of physical disability,
occurring separately from relapses, in patients with MS.

- Control subjects will be male or female, between the ages 18 to 70 years, of any race,
with no symptoms of MS.

Exclusion Criteria:

- Children are excluded from the study because MS is generally a disease of young adult
onset and is rare in children.

- Evidence of infection or communicable disease, cancer or other known systemic disease,
anti-coagulation, known bleeding disorder, illicit drug abuse, or change in
medications in the last 30 days (including treatment with steroids).

- Patients receiving any other immune modulating medications (steroids,
cyclophosphamide, mitoxantrone, methotrexate, mycophenolate mofetil, azathioprine,
IVIG or rituximab) in the prior thirty days will be excluded from the study
We found this trial at
1
site
1 Shields Ave
Sacramento, California 95616
(530) 752-1011
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