Development of “disease activity” prediction tools based on next-generation biomarkers in people with multiple sclerosis to inform prospective decisions about the personalised risk/benefit relationship of available treatments Nervous System Diseases
Conditions
Interventions
Study visits will be fully integrated into routine clinical care with data collected from hospital electronic records on treatment, relapse frequency and the Expanded Disability Status Scale (EDSS), M
Sponsors
NHS Lothian
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Cohort 1: Relapsing-remitting multiple sclerosis (RRMS) 1. Patients with RRMS fulfilling the 2017 McDonald criteria 2. Diagnosis of RRMS within 5 years of recruitment 3. Age = 18 years 4. Capacity to provide informed consent Cohort 2: Progressive MS and MS-related neurological disorders 1. Patients with MS fulfilling the 2017 McDonald criteria, including progressive MS at any stage 2. Diagnosis of RRMS outwith 5 years of recruitment 3. MS-related neurological disorders such as neuromyelitis optica spectrum disorder, clinically silent MS, chronic inflammatory demyelinating polyneuropathy and other neuroinflammatory or neurological disorders 4. Age = 18 years 5. Capacity to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Age < 18 years at recruitment 2. Contraindication to MR brain imaging 3. Patient is outside NHS Lothian or NHS Highland
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The development, validation and prediction of precision biomarkers for disease activity will be informed by measuring data collected from clinical, laboratory, and longitudinal neuroimaging assessments at the baseline visit, and 1- and 2-year follow-up visits | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measure data collection is undertaken at the baseline visit, and 1- and 2-year follow-up visits: 1. The difference in “precision biomarkers” between a real-world NHS setting and a research setting will be measured using comparative analysis at the time of biomarker assessment 2. The proportion of patients (MS of all subtypes and MS-related neurological diseases) who have disease activity identified using precision biomarkers that would not have otherwise been detected will be determined using retrospective review of clinical and biomarker data at the point of diagnosis or follow-up 3. Understanding of precision biomarker results by patients who request to see their results will be assessed using patient feedback or survey methods at the time results are shared | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactDavid;Judith Hunt;Watt
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Outcome results
None listed