MS-ResearchBiomarkerS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Primary Progressive, Multiple Sclerosis, Secondary Progressive. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Investigating the Longitudinal Relationships Between Visual Pathway Injury, Radiological and Blood Biomarkers in Multiple Sclerosis and Related Disorders
Overview
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.
Primary outcome measures
- Identifying risk factors for disability progression [Time frame: 10 years]
Secondary outcome measures (3)
- Effect of disease modifying therapy [Time frame: 10 years]
- Identify factors associated with visual disability and optic neuropathy in multiple sclerosis and related disorders [Time frame: 10 years]
- Identify serum, genetic, and stem cell-derived biomarkers influencing disability risks [Time frame: 10 years]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Cedars-Sinai Medical Center — Los Angeles
Publications
- Tayem AJ, Liu A, Manukyan S, Subhi M, Luskin E, Quah B, Nair SM, Has Silemek AC, Zabala G, Cui Y, Locke L, Barreras P, Kaisey M, Calsavara V, Reich DS, Sicotte NL, Sati P, Al-Louzi O. Paramagnetic Rim Lesions Are Associated With Trans-Synaptic Degeneration of the Visual Pathway in Multiple Sclerosis. Ann Clin Transl Neurol. 2026 Mar 17. doi: 10.1002/acn3.70352. Online ahead of print. PMID 41841206
Identifiers
NCT: NCT05204459 · STUDY00001690