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NCT04496830Completed

SPINCOMS Biomarker Study

Cerebrospinal Fluid-biomarkers-based Diagnostic and Prognostic Models for Multiple Sclerosis

Source: ClinicalTrials.gov · Last updated 11 Sept 2025

Brief summary (registry, in English)

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. This study will also look to identify biomarkers that could be used for the prediction, at the time of diagnosis, of the future disease clinical course and response to therapy. The SOMAscan assay will be used for CSF samples analysis.

Status (registry)
Completed
Study type
Observational
Enrollment
161 (actual)
First submitted
27 Jul 2020
Start date
15 Jun 2020
Primary completion date
24 Nov 2023
Lead sponsor
Washington University School of Medicine
NCT number
NCT04496830

What you commit to

  • Study type: Observational
  • Participants enrolled: 161
  • From 15 Jun 2020 to the primary completion date, 24 Nov 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Washington University in St. Louis
Coordinator of this site? Confirm its status		St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.