MS-ResearchBiomarkerS

Recruiting

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

• Registration Number: NCT05204459
• Lead Sponsor: Cedars-Sinai Medical Center

Brief 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.

Study Timeline

• Study Start: 2021-11-11
• Study First Submitted: 2022-01-11
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-24
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06
• Primary Completion: 2041-11-11
• Study Completion: 2041-11-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Subjects who meet any one of the following diagnostic criteria:

  • Diagnosis of MS, CIS,or RIS based on the 2017 revised McDonald criteria.
  • Diagnosis of NMOSD based on the 2015 revised NMOSD consensus diagnostic criteria.
  • Diagnosis of myelin oligodendrocyte glycoprotein (MOG)-related encephalomyelitis, optic neuritis, or other associated disease.
  • Diagnosis of neurological disorders other than MSRD.
  • Healthy volunteer.

• Age ≥18.

• Able to give informed consent.

Exclusion Criteria

• Patients will be excluded from the MRI portions of the study if they have a contraindication to MRI(metallic implantsor foreign bodies, claustrophobia, MRI-incompatible pacemakers, MRI- incompatible prosthetic heart valves).
• Patients will be excluded from the MRI portions of the study if they are pregnant, but their demographic, clinical information,and disability measures may still be captured under the study.
• Patients will be excluded from the visual assessment portions of the study if they have had any recent ocular surgery (within the past two months), refractive errors of greater than or equal to ±6 diopters or other eye diseases that may affect or confound OCT/OCTA measurements (ex., age-related macular degeneration, advanced geographic atrophy, diabetic retinopathy, glaucoma).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identifying risk factors for disability progression	10 years	To investigate whether combining information from peripheral blood biomarkers, retinal structural, visual function, as well as historical and ongoing longitudinal MRIs (brain, cervical, and/or thoracic spinal cord) can predict quantitative disability progression risk

Secondary Outcome Measures

Name	Time	Method
Identify factors associated with visual disability and optic neuropathy in multiple sclerosis and related disorders	10 years	Using retinal structural and functional testing, this study will track longitudinal evolution of visual dysfunction and retinal injury
Identify serum, genetic, and stem cell-derived biomarkers influencing disability risks	10 years
Effect of disease modifying therapy	10 years	Assess the effect modification of various Food and Drug Administration(FDA)-approved disease modifying therapy on disability risk

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States