AzTrials
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Multiple SclerosisSPINCOMSNCT04496830

SPINCOMS Biomarker Study

An observational study of Multiple Sclerosis, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
How many people
161 participants
Where
1 siteUnited States
Study dates
15 Jun 2020to 24 Nov 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University in St Louis

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: 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.

Read the 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.

Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04496830
Study groupRoleWhat they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Biomarker Predicted Outcomes against NeurEx-based outcomes

    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).

    Measured: 3 years

  2. MS Severity Model Analyses

    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.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2020
  2. Study start15 Jun 2020
  3. Primary completion24 Nov 2023
  4. Study completion24 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04496830
Sponsor's protocol ID
202004205
Acronym
SPINCOMS
Status last verified
Sep 2025
First submitted
27 Jul 2020
Last updated
11 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Will be determined based whether or not recruitment numbers will be sufficient to power outcome analyses.

Publications

  • Kidd DP. Sarcoidosis of the central nervous system: clinical features, imaging, and CSF results. J Neurol. 2018 Aug;265(8):1906-1915. doi: 10.1007/s00415-018-8928-2. Epub 2018 Jun 19.

    PubMed 29922952

  • Barbour C, Kosa P, Komori M, Tanigawa M, Masvekar R, Wu T, Johnson K, Douvaras P, Fossati V, Herbst R, Wang Y, Tan K, Greenwood M, Bielekova B. Molecular-based diagnosis of multiple sclerosis and its progressive stage. Ann Neurol. 2017 Nov;82(5):795-812. doi: 10.1002/ana.25083.

    PubMed 29059494

  • Weideman AM, Tapia-Maltos MA, Johnson K, Greenwood M, Bielekova B. Meta-analysis of the Age-Dependent Efficacy of Multiple Sclerosis Treatments. Front Neurol. 2017 Nov 10;8:577. doi: 10.3389/fneur.2017.00577. eCollection 2017.

    PubMed 29176956

  • Kosa P, Komori M, Waters R, Wu T, Cortese I, Ohayon J, Fenton K, Cherup J, Gedeon T, Bielekova B. Novel composite MRI scale correlates highly with disability in multiple sclerosis patients. Mult Scler Relat Disord. 2015 Nov;4(6):526-35. doi: 10.1016/j.msard.2015.08.009. Epub 2015 Aug 28.

    PubMed 26590659

  • Koga S, Aoki N, Uitti RJ, van Gerpen JA, Cheshire WP, Josephs KA, Wszolek ZK, Langston JW, Dickson DW. When DLB, PD, and PSP masquerade as MSA: an autopsy study of 134 patients. Neurology. 2015 Aug 4;85(5):404-12. doi: 10.1212/WNL.0000000000001807. Epub 2015 Jul 2.

    PubMed 26138942

  • Filippi M, Preziosa P, Meani A, Ciccarelli O, Mesaros S, Rovira A, Frederiksen J, Enzinger C, Barkhof F, Gasperini C, Brownlee W, Drulovic J, Montalban X, Cramer SP, Pichler A, Hagens M, Ruggieri S, Martinelli V, Miszkiel K, Tintore M, Comi G, Dekker I, Uitdehaag B, Dujmovic-Basuroski I, Rocca MA. Prediction of a multiple sclerosis diagnosis in patients with clinically isolated syndrome using the 2016 MAGNIMS and 2010 McDonald criteria: a retrospective study. Lancet Neurol. 2018 Feb;17(2):133-142. doi: 10.1016/S1474-4422(17)30469-6. Epub 2017 Dec 21.

    PubMed 29275979

  • Kosa P, Barbour C, Wichman A, Sandford M, Greenwood M, Bielekova B. NeurEx: digitalized neurological examination offers a novel high-resolution disability scale. Ann Clin Transl Neurol. 2018 Sep 24;5(10):1241-1249. doi: 10.1002/acn3.640. eCollection 2018 Oct.

    PubMed 30349859

  • Weideman AM, Barbour C, Tapia-Maltos MA, Tran T, Jackson K, Kosa P, Komori M, Wichman A, Johnson K, Greenwood M, Bielekova B. New Multiple Sclerosis Disease Severity Scale Predicts Future Accumulation of Disability. Front Neurol. 2017 Nov 10;8:598. doi: 10.3389/fneur.2017.00598. eCollection 2017.

    PubMed 29176958

  • Hawker K, O'Connor P, Freedman MS, Calabresi PA, Antel J, Simon J, Hauser S, Waubant E, Vollmer T, Panitch H, Zhang J, Chin P, Smith CH; OLYMPUS trial group. Rituximab in patients with primary progressive multiple sclerosis: results of a randomized double-blind placebo-controlled multicenter trial. Ann Neurol. 2009 Oct;66(4):460-71. doi: 10.1002/ana.21867.

    PubMed 19847908

  • Montalban X, Hauser SL, Kappos L, Arnold DL, Bar-Or A, Comi G, de Seze J, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Rammohan KW, Selmaj K, Traboulsee A, Sauter A, Masterman D, Fontoura P, Belachew S, Garren H, Mairon N, Chin P, Wolinsky JS; ORATORIO Clinical Investigators. Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):209-220. doi: 10.1056/NEJMoa1606468. Epub 2016 Dec 21.

    PubMed 28002688

  • Kosa P, Ghazali D, Tanigawa M, Barbour C, Cortese I, Kelley W, Snyder B, Ohayon J, Fenton K, Lehky T, Wu T, Greenwood M, Nair G, Bielekova B. Development of a Sensitive Outcome for Economical Drug Screening for Progressive Multiple Sclerosis Treatment. Front Neurol. 2016 Aug 15;7:131. doi: 10.3389/fneur.2016.00131. eCollection 2016.

    PubMed 27574516

  • Chen R, Mias GI, Li-Pook-Than J, Jiang L, Lam HY, Chen R, Miriami E, Karczewski KJ, Hariharan M, Dewey FE, Cheng Y, Clark MJ, Im H, Habegger L, Balasubramanian S, O'Huallachain M, Dudley JT, Hillenmeyer S, Haraksingh R, Sharon D, Euskirchen G, Lacroute P, Bettinger K, Boyle AP, Kasowski M, Grubert F, Seki S, Garcia M, Whirl-Carrillo M, Gallardo M, Blasco MA, Greenberg PL, Snyder P, Klein TE, Altman RB, Butte AJ, Ashley EA, Gerstein M, Nadeau KC, Tang H, Snyder M. Personal omics profiling reveals dynamic molecular and medical phenotypes. Cell. 2012 Mar 16;148(6):1293-307. doi: 10.1016/j.cell.2012.02.009.

    PubMed 22424236

  • Bridel C, Eijlers AJC, van Wieringen WN, Koel-Simmelink M, Leurs CE, Schoonheim MM, Killestein J, Teunissen CE. No Plasmatic Proteomic Signature at Clinical Disease Onset Associated With 11 Year Clinical, Cognitive and MRI Outcomes in Relapsing-Remitting Multiple Sclerosis Patients. Front Mol Neurosci. 2018 Oct 31;11:371. doi: 10.3389/fnmol.2018.00371. eCollection 2018.

    PubMed 30429773

  • Bergman J, Dring A, Zetterberg H, Blennow K, Norgren N, Gilthorpe J, Bergenheim T, Svenningsson A. Neurofilament light in CSF and serum is a sensitive marker for axonal white matter injury in MS. Neurol Neuroimmunol Neuroinflamm. 2016 Aug 2;3(5):e271. doi: 10.1212/NXI.0000000000000271. eCollection 2016 Oct.

    PubMed 27536708

  • Kuhle J, Barro C, Disanto G, Mathias A, Soneson C, Bonnier G, Yaldizli O, Regeniter A, Derfuss T, Canales M, Schluep M, Du Pasquier R, Krueger G, Granziera C. Serum neurofilament light chain in early relapsing remitting MS is increased and correlates with CSF levels and with MRI measures of disease severity. Mult Scler. 2016 Oct;22(12):1550-1559. doi: 10.1177/1352458515623365. Epub 2016 Jan 11.

    PubMed 26754800

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biomarker Predicted Outcomes against NeurEx-based outcomes (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04496830, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025; AzTrials last refreshed its copy on 30 Oct 2026.

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