Status:
COMPLETED
SPINCOMS Biomarker Study
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
University of Colorado, Denver
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Brief Summary
To determine if biomarker-based CSF testing is reliably detecting differences between patients with Multiple Sclerosis (MS), different MS-subtypes, and other central nervous system (CNS) diseases. Thi...
Detailed Description
Using machine learning, the investigators have developed from SOMAScan: 1. A molecular diagnostic test that differentiates MS from other inflammatory and non-inflammatory central nervous system (CNS)...
Eligibility Criteria
Inclusion
- MS Patients selection criteria
- Lumbar puncture (LP) in the untreated stage with cryopreserved CSF (serum/blood optional) with consent to use it for future research
- ≥ 3 and ≤ 10 years of follow-up from LP
- At time of LP untreated and not treated with steroid or off steroids ≥ one month
- Available/willing to come for in-person follow-up
- Available/willing to sign the NIH 09-I-0032 "Sample processing only" consent form
- Diagnosis of MS based on 2017 McDonald criteria at time of follow-up visit
- Non-MS Patients selection criteria Required: 25 Non-Inflammatory Neurological Disease (NIND), 25 Other Inflammatory Neurological Disease (OIND)
- Lumbar puncture (LP) in the untreated stage with cryopreserved CSF (serum/blood optional) with consent to use it for future research
- ≥ 3 and ≤ 10 years of follow-up from LP
- At time of LP untreated and not treated with steroid or off steroids ≥ one month
- Up to date contact information
- Available/willing to sign the NIH 09-I-0032 "Sample processing only" consent form
- Diagnosis:
- NIND: e.g., ischemic-gliotic changes, CADASIL and other leukodystrophies, migraines, ischemic spinal cord lesions etc OIND: e.g. CNS Sjogren's, SLE, vasculitis, CNS infections, MOG-associated disorders, NMO spectrum disorders (NMOSD)
Exclusion
Key Trial Info
Start Date :
June 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 24 2023
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT04496830
Start Date
June 15 2020
End Date
November 24 2023
Last Update
September 11 2025
Active Locations (1)
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1
Washington University in St Louis
St Louis, Missouri, United States, 63110