A Pilot Study to Assess microRNA Biomarkers in Early and Later Stage Multiple Sclerosis
This study will look at the blood and cerebrospinal fluid of consented participants who either have early stage multiple sclerosis (clinically isolated syndrome) or who have later stage (secondary progressive multiple sclerosis), or participants who do not have any neurological or autoimmune illness. Biomarkers and microRNA will be assessed for group differences.
Secondary Progressive Multiple Sclerosis
Clinically Isolated Syndrome
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||A Pilot Study to Assess microRNA Biomarkers in Early and Later Stage Multiple Sclerosis|
- To characterize differences in microRNA profile and cell product patterns between early and later stage multiple sclerosis. [ Time Frame: baseline ] [ Designated as safety issue: No ]
- Correlate microRNA profiles with clinical and CSF inflammation indexes [ Time Frame: baseline ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Cerebrospinal fluid and blood may be stored for future immunological, cell product and microRNA testing related to the primary outcome of the this study.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Secondary Progressive MS (SPMS)
Secondary Progressive MS participants
Clinically Isolated Syndrome (CIS)
Clinically isolated syndrome participants
No immunological or neurological illnesses.
Multiple Sclerosis is a chronic autoimmune disorder of the central nervous system. While there are current immunomodulatory therapies that have been shown to be efficacious in the early stages of MS, these therapies are less potent in the later phases of MS. We can look at magnetic resonance imaging with gadolinium to measure active disease but it does not detect axonal degeneration. Therefore, there is a need to identify other biomarkers that may be used to diagnose MS and predict disease progression. Biomarkers found in the cerebrospinal fluid (CSF) are in closer proximity to the inflammatory lesion sites and are more sensitive.
This pilot study seeks to characterize differences in microRNA profiles and cell products in the early and later stages of MS, with the hope that that microRNA profiles could then be correlated to clinical and CSF inflammation indexes. CSF will be obtained from 45 participants.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737372
|Contact: Tammy Hoyt, MSfirstname.lastname@example.org|
|Contact: Laura Burr, RNemail@example.com|
|United States, Utah|
|Rocky Mountain MS Clinic||Recruiting|
|Salt Lake City, Utah, United States, 84103|
|Contact: Tammy Hoyt, MS 801-408-4584 firstname.lastname@example.org|
|Principal Investigator: John F Foley, MD|
|Sub-Investigator: Viktoria Kaplan, MD|
|Principal Investigator:||John F Foley, MD||Rocky Mountain MS Research Group, LLC|