MS-ResearchBiomarkerS

Multiple Sclerosis Clinical Trial

— MS-ReBS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05204459
• Other study ID #: STUDY00001690
• Status: Recruiting
• Start date: November 11, 2021
• Est. completion date: November 11, 2041

Study information

• Verified date: February 2024
• Source: Cedars-Sinai Medical Center
• Contact: Omar Al-Louzi, MD
• Phone: (310) 423-4008
• Email: omar.allouzi[@]cshs.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 11, 2041
• Est. primary completion date: November 11, 2041
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Autoimmune Diseases
• Autoimmune Diseases of the Nervous System
• Clinically Isolated Syndrome
• Healthy Aging
• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Multiple Sclerosis, Primary Progressive
• Multiple Sclerosis, Relapsing-Remitting
• Multiple Sclerosis, Secondary Progressive
• Nervous System Diseases
• Neurologic Autoimmune Disease
• Neurologic Disorder
• Neuromyelitis Optica
• Neuromyelitis Optica Spectrum Disorders
• Radiologically Isolated Syndrome
• Sclerosis
• Syndrome

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Cedars-Sinai Clinical Research Website