Clinical trial NCT05204459: MS-ResearchBiomarkerS
Official title: Investigating the Longitudinal Relationships Between Visual Pathway Injury, Radiological and Blood Biomarkers in Multiple Sclerosis and Related Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Keywords: 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
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with the following conditions or healthy volunteers are eligible to participate in the study:

1. Multiple sclerosis (MS), clinically isolated syndrome (CIS), or radiologically isolated syndrome (RIS)
2. Neuromyelitis optica spectrum disorders (NMOSD)
3. Myelin oligodendrocyte glycoprotein (MOG) antibody associated disorders (MOGAD)
4. Neurological disorder other than MS and related disorders
5. Healthy volunteers

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.

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).

Primary outcomes:
measure: Identifying risk factors for disability progression
timeFrame: 10 years
Secondary outcomes:
measure: Effect of disease modifying therapy
timeFrame: 10 years
measure: Identify factors associated with visual disability and optic neuropathy in multiple sclerosis and related disorders
timeFrame: 10 years
measure: Identify serum, genetic, and stem cell-derived biomarkers influencing disability risks
timeFrame: 10 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Omar Al-Louzi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars-Sinai Medical Center
name: Marwa Kaisey, MD
role: STUDY_DIRECTOR
affiliation: Cedars-Sinai Medical Center
name: Brooke Guerrero, MD
role: STUDY_DIRECTOR
affiliation: Cedars-Sinai Medical Center
name: Laura Locke, CRNP
role: STUDY_DIRECTOR
affiliation: Cedars-Sinai Medical Center
name: Pascal Sati, PhD
role: STUDY_DIRECTOR
affiliation: Cedars-Sinai Medical Center
name: Nancy Sicotte, MD
role: STUDY_CHAIR
References: