- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00704834
Gene Expression Profiles in Multiple Sclerosis (MS)
February 20, 2020 updated by: University of California, Davis
Gene Expression Profiles in Patients With Multiple Sclerosis
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
46
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Sacramento, California, United States, 95817
- University of California, Davis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
Normal Controls
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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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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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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
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35 cc of peripheral blood will be obtained by venipuncture from each subject.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine MS-specific peripheral blood gene expression patterns
Time Frame: 3 years
|
3 years
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Determine differences in peripheral blood gene expression patterns between subgroups of MS patients
Time Frame: 3 years
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3 years
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Determine whether there are specific SNPs correlated with altered gene expression profiles in multiple sclerosis
Time Frame: 3 years
|
3 years
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Determine MS-specific peripheral blood inflammatory marker profiles
Time Frame: 3 years
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3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (ACTUAL)
July 5, 2017
Study Completion (ACTUAL)
July 5, 2017
Study Registration Dates
First Submitted
June 23, 2008
First Submitted That Met QC Criteria
June 23, 2008
First Posted (ESTIMATE)
June 25, 2008
Study Record Updates
Last Update Posted (ACTUAL)
February 21, 2020
Last Update Submitted That Met QC Criteria
February 20, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 291796
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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