Gene Expression Profiles in Multiple Sclerosis (MS)
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ClinicalTrials.gov Identifier: NCT00704834 |
Recruitment Status
:
Suspended
(Temporarily suspended due to funding issues)
First Posted
: June 25, 2008
Last Update Posted
: July 18, 2017
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Condition or disease | Intervention/treatment |
---|---|
Multiple Sclerosis | Other: Blood Draw |
Study Type : | Observational |
Estimated Enrollment : | 120 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Gene Expression Profiles in Patients With Multiple Sclerosis |
Study Start Date : | March 2006 |
Estimated Primary Completion Date : | August 2027 |
Estimated Study Completion Date : | August 2027 |

Group/Cohort | Intervention/treatment |
---|---|
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.
|
- 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

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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 |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00704834
United States, California | |
University of California, Davis | |
Sacramento, California, United States, 95817 |
Principal Investigator: | Michelle Apperson, MD, PhD | University of California, Davis |
Responsible Party: | University of California, Davis |
ClinicalTrials.gov Identifier: | NCT00704834 History of Changes |
Other Study ID Numbers: |
200614150 |
First Posted: | June 25, 2008 Key Record Dates |
Last Update Posted: | July 18, 2017 |
Last Verified: | July 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
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 |