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Gene Expression Profiles in Multiple Sclerosis (MS)
This study has suspended participant recruitment.
(Temporarily suspended due to funding issues)
Sponsor:
University of California, Davis
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00704834
First received: June 23, 2008
Last updated: May 1, 2017
Last verified: May 2017
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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 | Other: 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 ]
- 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 ]
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 2017 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Normal Controls
|
Other: Blood Draw
35 cc of peripheral blood will be obtained by venipuncture from each subject.
|
|
2
Patients with a clinically isolated syndrome (CIS)
|
Other: 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
|
Other: 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
|
Other: 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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
University of California, Davis
Investigators
| Principal Investigator: | Michelle Apperson, MD, PhD | University of California, Davis |
More Information
| Responsible Party: | University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT00704834 History of Changes |
| Other Study ID Numbers: |
200614150 |
| Study First Received: | June 23, 2008 |
| Last Updated: | May 1, 2017 |
| Individual Participant Data | |
| Plan to Share IPD: | No |
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:
|
Sclerosis Multiple Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on June 22, 2017