Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatment blood draw
Sponsor Michelle Apperson, MD
Start date March 2006
End date June 2015
Trial size 120 participants
Trial identifier NCT00704834, 200614150

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Normal Controls
blood draw
35 cc of peripheral blood will be obtained by venipuncture from each subject.
Patients with a clinically isolated syndrome (CIS)
blood draw
35 cc of peripheral blood will be obtained by venipuncture from each subject.
Patients with relapsing, remitting Multiple Sclerosis (RRMS) who are not on treatment
blood draw
35 cc of peripheral blood will be obtained by venipuncture from each subject.
Patients with Chronic Progressive Multiple Sclerosis who are not on treatment
blood draw
35 cc of peripheral blood will be obtained by venipuncture from each subject.

Primary Outcomes

Measure
Determine MS-specific peripheral blood gene expression patterns
time frame: 3 years
Determine differences in peripheral blood gene expression patterns between subgroups of MS patients
time frame: 3 years
Determine whether there are specific SNPs correlated with altered gene expression profiles in multiple sclerosis
time frame: 3 years
Determine MS-specific peripheral blood inflammatory marker profiles
time frame: 3 years

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Gene Expression Profiles in Patients With Multiple Sclerosis
Principal investigator Michelle Apperson, MD, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by University of California, Davis.