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Sponsored by: |
University of California, Davis |
Information provided by: | University of California, Davis |
ClinicalTrials.gov Identifier: | NCT00704834 |
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 |
MedlinePlus related topics: | Multiple Sclerosis |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Gene Expression Profiles in Patients With Multiple Sclerosis |
35cc of peripheral blood will be obtained from each subject via venipuncture.
Estimated Enrollment: | 120 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
1
Normal Controls
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Procedure: Blood Draw
35 cc of peripheral blood will be obtained by venipuncture from each subject.
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2
Patients with a clinically isolated syndrome (CIS)
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Procedure: Blood Draw
35 cc of peripheral blood will be obtained by venipuncture from each subject.
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3
Patients with relapsing, remitting Multiple Sclerosis (RRMS) who are not on treatment
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Procedure: Blood Draw
35 cc of peripheral blood will be obtained by venipuncture from each subject.
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4
Patients with Chronic Progressive Multiple Sclerosis who are not on treatment
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Procedure: Blood Draw
35 cc of peripheral blood will be obtained by venipuncture from each subject.
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
Contact: Michelle Apperson, MD, PhD | 530-754-5008 | michelle.apperson@ucdmc.ucdavis.edu |
United States, California | |||||
University of California, Davis | Recruiting | ||||
Sacramento, California, United States, 95817 | |||||
Contact: Michelle Apperson, MD, PhD 916-754-5008 michelle.apperson@ucdmc.ucdavis.edu | |||||
Principal Investigator: Michelle Apperson, MD, PhD |
University of California, Davis |
Principal Investigator: | Michelle Apperson, MD, PhD | University of California, Davis |
Responsible Party: | University of California, Davis ( Michelle Apperson, MD ) |
Study ID Numbers: | 200614150 |
First Received: | June 23, 2008 |
Last Updated: | June 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00704834 |
Health Authority: | United States: Institutional Review Board |
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