Gene Expression Profiles in Multiple Sclerosis (MS)

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Blood Draw

• Registration Number: NCT00704834
• Lead Sponsor: University of California, Davis

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-25
• Primary Completion: 2017-07-05
• Study Completion: 2017-07-05
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
3	Blood Draw	Patients with relapsing, remitting Multiple Sclerosis (RRMS) who are not on treatment
4	Blood Draw	Patients with Chronic Progressive Multiple Sclerosis who are not on treatment
2	Blood Draw	Patients with a clinically isolated syndrome (CIS)
1	Blood Draw	Normal Controls

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of California, Davis; 🇺🇸 Sacramento, California, United States