SPINCOMS Biomarker Study (SPINCOMS)

September 3, 2025 updated by: Washington University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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) diseases (area under receiver-operator characteristic curve-AUROC of 0.98);
  2. A molecular test that differentiates relapsing-remitting MS from progressive MS variants (AUROC of 0.91); and
  3. A molecular test that predicts future rates of disability progression, concordance coefficient of 0.425 (p<0.001).

Because these results are derived from a single research center (NIAID/NDS), it is imperative to determine their performance in real clinical practice settings as a necessary step for their potential regulatory approval.

Consequently, his application has 2 specific aims:

AIM 1. To independently validate afore-mentioned CSF-biomarker-based tests for their clinical value within the multicenter Spinal fluid Consortium for MS (SPINCOMS). In Aim 1, each of the 3 defined tests will be validated in 100 new SPINCOMS patients. To validate the prognostic test, 100 MS patients with CSF collected at least 3 years ago will be evaluated at follow-up examination with standardized clinical outcomes. CSF will be analyzed blinded using pre-defined statistical models.

AIM 2. To explore whether collected CSF-biomarkers point towards pathogenic heterogeneity that may predict patient-specific efficacy for different disease-modifying treatments (DMTs) or identify pathogenic mechanisms not targeted by current DMTs. In Aim 2, clustering analysis will assess pathogenic heterogeneity and explore potential predictors of response to therapy.

Study Type

Observational

Enrollment (Actual)

161

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University in St Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Relapsing-remitting multiple sclerosis patients

Progressive multiple sclerosis patients

Patients with non-inflammatory neurological diseases (NIND): e.g., ischemic-gliotic changes, CADASIL and other leukodystrophies, migraines, ischemic spinal cord lesions.

Patients with other inflammatory neurological diseases (OIND):e.g. CNS Sjogren's, SLE, vasculitis, CNS infections, MOG-associated disorders, NMO spectrum disorders (NMOSD)

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Relapsing Remitting Multiple Sclerosis
  • Blood sample collection
  • Vital signs, weight, height and BMI.
  • Complete neurological examination documented in NeurEx (recorded with an iPAD).
  • Clinical data questionnaire
  • 25FW & non-dominant hand 9HPT (required for calculating CombiWISE & MS-DSS).
  • Smartphone Apps (include 25FW, SDMT and tests that correlate highly w 9HPT - can be acquired in patient-autonomous manner with minimal assistance).
  • Optical Coherence Tomography (OCT)
  • CSF Analysis
Progressive Multiple Sclerosis
  • Blood sample collection
  • Vital signs, weight, height and BMI.
  • Complete neurological examination documented in NeurEx (recorded with an iPAD).
  • Clinical data questionnaire
  • 25FW & non-dominant hand 9HPT (required for calculating CombiWISE & MS-DSS).
  • Smartphone Apps (include 25FW, SDMT and tests that correlate highly w 9HPT - can be acquired in patient-autonomous manner with minimal assistance).
  • Optical Coherence Tomography (OCT)
  • CSF Analysis
Non-Inflammatory Neurological Diseases
  • Clinical data questionnaire
  • CSF Analysis
Other Non-Inflammatory Neurological Diseases
  • Clinical data questionnaire
  • CSF Analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker Predicted Outcomes against NeurEx-based outcomes
Time Frame: 3 years
CSF-biomarker-predicted outcomes against measured NeurEx-based outcomes, considering a Bonferroni-adjusted significance level 0.05/3 = 0.017 (to adjust for 3 tests).
3 years
MS Severity Model Analyses
Time Frame: 3 years
As secondary analyses of MS severity model,assessment of correlations between CSF-biomarker-predicted outcomes and more traditional MS outcomes. Specifically, correlate CSF-biomarker-based scores of MS severity and MSSS, ARMSSS and by MS-DSS, calculated from the follow-up visit scores. Based on power calculations, 100 relevant patients/classifier will provide > 90% power to externally validate all 3 Somascan CSF-biomarker-based models.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

University of Colorado, Denver
National Institute of Allergy and Infectious Diseases (NIAID)
University of Ottawa
Montana State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Actual)

November 24, 2023

Study Completion (Actual)

November 24, 2023

Study Registration Dates

First Submitted

July 27, 2020

First Submitted That Met QC Criteria

July 30, 2020

First Posted (Actual)

August 3, 2020

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 3, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202004205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Will be determined based whether or not recruitment numbers will be sufficient to power outcome analyses.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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