Gene Expression Profiles in Multiple Sclerosis (MS)

NCT00704834 | Completed

• 1 other identifier: 291796
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis; Chronic Progressive Multiple Sclerosis; Clinically Isolated Syndrome; Normal Controls; Blood Draw

Outcome Measures

Primary Outcomes (4)

• Determine MS-specific peripheral blood gene expression patterns

  3 years

• Determine differences in peripheral blood gene expression patterns between subgroups of MS patients

  3 years

• Determine whether there are specific SNPs correlated with altered gene expression profiles in multiple sclerosis

  3 years

• Determine MS-specific peripheral blood inflammatory marker profiles

  3 years

Study Arms (4)

1

Normal Controls

Other: Blood Draw

2

Patients with a clinically isolated syndrome (CIS)

Other: Blood Draw

3

Patients with relapsing, remitting Multiple Sclerosis (RRMS) who are not on treatment

Other: Blood Draw

4

Patients with Chronic Progressive Multiple Sclerosis who are not on treatment

Other: Blood Draw

Interventions

Blood Draw OTHER

35 cc of peripheral blood will be obtained by venipuncture from each subject.

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

35cc of peripheral blood will be obtained from each subject via venipuncture.

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Michelle Apperson, MD, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 25, 2008
• Study Start: March 1, 2006
• Primary Completion: July 5, 2017
• Study Completion: July 5, 2017
• Last Updated: February 21, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)