Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-26 @ 3:24 AM
Study NCT ID:
NCT05204459
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2022-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MS-ResearchBiomarkerS
Sponsor:
Cedars-Sinai Medical Center
Organization:
Study Overview
Official Title:
Investigating the Longitudinal Relationships Between Visual Pathway Injury, Radiological and Blood Biomarkers in Multiple Sclerosis and Related Disorders
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MS-ReBS
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: