Gene Expression Profiles in Multiple Sclerosis (MS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Michelle Apperson, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00704834
First received: June 23, 2008
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Multiple Sclerosis
Procedure: Blood Draw

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gene Expression Profiles in Patients With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Determine MS-specific peripheral blood gene expression patterns [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Determine differences in peripheral blood gene expression patterns between subgroups of MS patients [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Determine whether there are specific SNPs correlated with altered gene expression profiles in multiple sclerosis [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Determine MS-specific peripheral blood inflammatory marker profiles [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

35cc of peripheral blood will be obtained from each subject via venipuncture.


Estimated Enrollment: 120
Study Start Date: March 2006
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Normal Controls
Procedure: Blood Draw
35 cc of peripheral blood will be obtained by venipuncture from each subject.
2
Patients with a clinically isolated syndrome (CIS)
Procedure: Blood Draw
35 cc of peripheral blood will be obtained by venipuncture from each subject.
3
Patients with relapsing, remitting Multiple Sclerosis (RRMS) who are not on treatment
Procedure: Blood Draw
35 cc of peripheral blood will be obtained by venipuncture from each subject.
4
Patients with Chronic Progressive Multiple Sclerosis who are not on treatment
Procedure: Blood Draw
35 cc of peripheral blood will be obtained by venipuncture from each subject.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adult subjects aged 18 to 70 will be enrolled. There will be four study groups: patients with a clinically isolated syndrome (CIS), patients with untreated relapsing-remitting MS (RR-MS), patients with chronic, progressive MS (CPMS), and age- and gender-matched control subjects without MS. Patients of both sexes and all races will be recruited into the study without bias.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704834

Locations
United States, California
University of California, Davis
Sacramento, California, United States, 95817
Sponsors and Collaborators
Michelle Apperson, MD
Investigators
Principal Investigator: Michelle Apperson, MD, PhD University of California, Davis
  More Information

No publications provided

Responsible Party: Michelle Apperson, MD, Principal Investigator, University of California, Davis
ClinicalTrials.gov Identifier: NCT00704834     History of Changes
Other Study ID Numbers: 200614150
Study First Received: June 23, 2008
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Multiple Sclerosis
Relapsing Remitting Multiple Sclerosis
Chronic Progressive Multiple Sclerosis
Clinically Isolated Syndrome
Normal Controls
Blood Draw

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014