Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
161 participants
Study Classification
OBSERVATIONAL
Study Start Date
2020-06-15
Study Completion Date
2023-11-24
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Multiple Sclerosis
Study Design
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Observational Model Type
OTHER
Study Time Perspective
OTHER
Study Groups
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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
No interventions assigned to this group
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
No interventions assigned to this group
Non-Inflammatory Neurological Diseases
* Clinical data questionnaire
* CSF Analysis
No interventions assigned to this group
Other Non-Inflammatory Neurological Diseases
* Clinical data questionnaire
* CSF Analysis
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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)
* 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)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Sponsor Role
collaborator
University of Colorado, Denver
OTHER
Sponsor Role
collaborator
University of Ottawa
OTHER
Sponsor Role
collaborator
Montana State University
OTHER
Sponsor Role
collaborator
Washington University School of Medicine
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Washington University in St Louis
St Louis, Missouri, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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202004205
Identifier Type: -
Identifier Source: org_study_id
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