Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Biomarkers
  • Clinically Isolated Syndrome
  • Magnetic Resonance Imaging
  • Multiple Sclerosis
  • Radiologically Isolated Syndrome
Type
Observational
Design
Observational Model: Case-ControlTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 30 years
Gender
Both males and females

Description

Specific Aims, among asymptomatic first degree relatives (FDRs), aged 18-30, of multiple sclerosis (MS) patients: Determine the prevalence of brain MRI lesions disseminated in space (DIS), consistent with MS Gather data on potential risk factors or early signs related to MS development, including ma...

Specific Aims, among asymptomatic first degree relatives (FDRs), aged 18-30, of multiple sclerosis (MS) patients: Determine the prevalence of brain MRI lesions disseminated in space (DIS), consistent with MS Gather data on potential risk factors or early signs related to MS development, including markers for: genes, immunological function, environmental factors, neuroaxonal damage, Vitamin D levels, lipid metabolism, activity levels, mood abnormalities, and cognitive function. From this, develop a risk factor score, incorporating all relevant potential markers of increased risk of DIS. To use this pilot, cross-sectional study as a base for development of a long-term, longitudinal, multi-center study to determine genetic and environmental risks for pre-symptomatic MS To create and maintain a biobank of specimens for future analysis as other potential biomarkers become available. Sequences to include Whole brain T1-weighted images acquired using 3-Dimensional fast spoiled-gradient recalled acquisitions (T1-3D-FSPGR) with 1 mm slice thickness and isotropic voxel dimensions. Whole brain 3-Dimensional Double Inversion Recovery (DIR) acquisition with 1.5 mm slice thickness. Whole brain T2-weighted Fluid Attenuated Inversion Recovery (FLAIR ) images with 1 mm slice thickness and isotropic voxel dimensions will be combined with Whole brain T2*-weighted segmented echo-planar imaging (segEPI) images with <=1 mm slice thickness and isotropic voxel dimensions to obtain FLAIR* images. Blood analysis for: Single Nucleotide Polymorphism analysis of greater than 200 known mutations associated with risk of MS, and do an human leukocyte antigen (HLA) analysis CD20 on CD4+ cell analysis B Cell Anergy analysis Lipid levels Viral serologies (HSV, EBV, CMV, VZV) Neurofilament Light Vitamin D levels Bioscreen analysis based on that from the Diabetes Autoimmunity Study in the Young (DAISY); and to include the Godin Leisure-Time Exercise Questionnaire (GLTEQ), which has been validated in both adults and children and a validated dietary/food frequency questionnaire. In addition perform a cognitive screen with a Symbol Digit Modality test. Blood will also be stored for future potential analysis, including peripheral blood mononuclear cells, serum, and Ribonucleic acid (RNA).

Tracking Information

NCT #
NCT03586986
Collaborators
Colorado School of Public Health
Investigators
Principal Investigator: John R Corboy, MD University of Colorado - Anschutz Medical Campus