PrecisionMS: Precision biomarkers for multiple sclerosis V1

  • Research type

    Research Study

  • Full title

    PrecisionMS: Clinical, laboratory, and neuroimaging predictors of disease activity in multiple sclerosis: an observational cohort study using datasets derived from routine standard of care.

  • IRAS ID

    322741

  • Contact name

    David Hunt

  • Contact email

    david.hunt@ed.ac.uk

  • Sponsor organisation

    University of Edinburgh

  • Clinicaltrials.gov Identifier

    N/A, N/A

  • Duration of Study in the UK

    5 years, 0 months, 1 days

  • Research summary

    Multiple sclerosis is a highly unpredictable neurological disease.

    PrecisionMS aims to identify and validate clinical, laboratory and neuroimaging factors that predict individual disease activity in a routine clinical practice setting. It is an observational study which builds on the related FutureMS studies which have generated such biomarkers from dedicated research blood tests, visits and MRIs. To bring these findings closer to “real-world” setting, PrecisionMS will generate these biomarkers from routine NHS clinical care investigations (for example, analyses of NHS standard of care brain scans rather than research brain scans).

    The fundamental aim of the FutureMS and Future MS2 studies has been the identification of biomarkers of prognostic relevance. This has demonstrated that blood biomarkers (such as neurofilament) and detailed analyses of brain MRIs can predict prognosis in Scottish MS populations. PrecisionMS is a critical step to implementation of such biomarkers into clinical practice, through evaluating their performance when generated from routine NHS clinical care investigations (blood tests and MRI).

    PrecisionMS will validate the predictive value of these biomarkers in the NHS clinic setting and develop tools to feed back these results in a way which improve MS patients' understanding of their disease.

    PrecisionMS is a Scotland-wide observational study that will be informed by, and analysed alongside, the FutureMS studies. 180 MS patients (diagnosed with relapsing-remitting MS within 5 years of recruitment) in NHS Lothian will be included in the study, and a further site will recruit in NHS Highland (40 patients). An additional cohort will recruit participants with more advanced MS or MS-related neurological disorders, such as neuromyelitis optica (n=100). Imaging and blood tests will be taken as part of routine clinical care. PrecisionMS will follow clinical progress of patients and analyse the predictive validity of these biomarkers.

  • REC name

    East Midlands - Derby Research Ethics Committee

  • REC reference

    23/EM/0194

  • Date of REC Opinion

    29 Aug 2023

  • REC opinion

    Further Information Favourable Opinion