Multiple SclerosisNCT00704834
Gene Expression Profiles in Multiple Sclerosis (MS)
An observational study of Multiple Sclerosis, run by University of California, Davis at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Blood Draw
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to 5 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Sacramento, California, 95817
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Blood Draw
- Keywords
- Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Clinically Isolated Syndrome, Normal Controls, Blood Draw
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawOther
35 cc of peripheral blood will be obtained by venipuncture from each subject.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Normal Controls Receives: Other: Blood Draw | |
| 2 | Patients with a clinically isolated syndrome (CIS) Receives: Other: Blood Draw | |
| 3 | Patients with relapsing, remitting Multiple Sclerosis (RRMS) who are not on treatment Receives: Other: Blood Draw | |
| 4 | Patients with Chronic Progressive Multiple Sclerosis who are not on treatment Receives: Other: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine MS-specific peripheral blood gene expression patterns
Measured: 3 years
Determine differences in peripheral blood gene expression patterns between subgroups of MS patients
Measured: 3 years
Determine whether there are specific SNPs correlated with altered gene expression profiles in multiple sclerosis
Measured: 3 years
Determine MS-specific peripheral blood inflammatory marker profiles
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2008 (estimated)
- Study startMar 2006
- Primary completion5 Jul 2017
- Study completion5 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Apperson, MD, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00704834
- Sponsor's protocol ID
- 291796
- Status last verified
- Feb 2020
- First submitted
- 23 Jun 2008
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression Profiles in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00704834
- Acronym / sponsor ID
- 291796
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Clinically Isolated Syndrome, Normal Controls, Blood Draw
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- 5 Jul 2017 (actual)
- Study completion
- 5 Jul 2017 (actual)
- First posted
- 25 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Blood DrawNormal Controls |
| 2 | – | Other: Blood DrawPatients with a clinically isolated syndrome (CIS) |
| 3 | – | Other: Blood DrawPatients with relapsing, remitting Multiple Sclerosis (RRMS) who are not on treatment |
| 4 | – | Other: Blood DrawPatients with Chronic Progressive Multiple Sclerosis who are not on treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Draw35 cc of peripheral blood will be obtained by venipuncture from each subject. | Other | 1, 2, 3, 4 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Apperson, MD, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine MS-specific peripheral blood gene expression patterns (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.