NCT05204459

MS-ResearchBiomarkerS

Investigating the Longitudinal Relationships Between Visual Pathway Injury, Radiological and Blood Biomarkers in Multiple Sclerosis and Related Disorders

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is being conducted to investigate risk factors for disability progression in Multiple Sclerosis and related disorders (MSRD). The primary goal is to assess whether combining information from visual assessment, blood markers, as well as historical and ongoing longitudinal MRIs of the brain, orbit (the part of the skull where eyes are located), and/or spinal cord can predict changes in quantitative disability measures related to MSRD and neurological disease.

Detailed description

Screening: Prospective participants will be screened at Cedars-Sinai Medical Center (CSMC) through a comprehensive review of their medical and MRI records done as part of standard of care to determine if they are eligible to participate in this study. If they never had an MRI at CSMC, they will be asked to provide records of an MRI done at another site. If the study team determines that they are eligible to continue participating, then they will move on to the main research study. Main Research Study: The following items will be collected as part of the main research study: * Demographic data and medical history, including medications, family, and social history * Complete a series of quantitative disability assessments, * Collection of historic MRI data obtained as part of standard of care Optional Sub-study: Participants are not required to take part in the optional sub-study and can choose which sub-study procedures they would want to undergo. Participants can say no to the sub-study, and still remain in the main study. The optional sub-study involves undergoing one or more of the procedures below: * Research blood draw * Additional blood sample for a genetic and/or stem cell sub-study * Visual assessment * Research MRI How long will participants be in the study? There is no prespecified end date for this study. Participants may remain in the main study as long as they are (1) willing to participate, (2) remain eligible for the study procedures, and (3) the study remains open. Compensation for Participating Participants will be provided a voucher to cover parking expenses at Cedars-Sinai Medical Center during their participation in this research study if they undergo the optional sub-study procedures.

Conditions

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Multiple Sclerosis, Primary Progressive
• Multiple Sclerosis, Secondary Progressive
• Clinically Isolated Syndrome
• Radiologically Isolated Syndrome
• Neuromyelitis Optica Spectrum Disorders
• Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
• Neurologic Autoimmune Disease
• Neurologic Disorder
• Healthy Aging

Timeline

• Start date: 2021-11-11
• Primary completion: 2041-11-11
• Completion: 2041-11-11
• First posted: 2022-01-24
• Last updated: 2024-02-06

Locations

1 site across 1 country: United States