| Creators: |
Bayas, Antonios and Mansmann, Ulrich and Ön, Begum I. and Hoffmann, Verena S. and Berthele, Achim and Mühlau, Mark and Kowarik, Markus C. and Krumbholz, Markus and Senel, Makbule and Steuerwald, Verena and Naumann, Markus and Hartberger, Julia and Kerschensteiner, Martin and Oswald, Eva and Ruschil, Christoph and Ziemann, Ulf and Tumani, Hayrettin and Vardakas, Ioannis and Albashiti, Fady and Kramer, Frank and Soto-Rey, Inaki and Spengler, Helmut and Mayer, Gerhard and Kestler, Hans A. and Kohlbacher, Oliver and Hagedorn, Marlien and Boeker, Martin and Kuhn, Klaus and Buchka, Stefan and Kohlmayer, Florian and Kirschke, Jan S. and Behrens, Lars and Zimmermann, Hanna and Bender, Benjamin and Sollmann, Nico and Havla, Joachim and Hemmer, Bernhard and ProVal-MS study group |
| Abstract (ENG): |
Introduction
In Multiple Sclerosis (MS), patients´ characteristics and (bio)markers that reliably predict the individual disease prognosis at disease onset are lacking. Cohort studies allow a close follow-up of MS histories and a thorough phenotyping of patients. Therefore, a multicenter cohort study was initiated to implement a wide spectrum of data and (bio)markers in newly diagnosed patients.
Methods
ProVal-MS (Prospective study to validate a multidimensional decision score that predicts treatment outcome at 24 months in untreated patients with clinically isolated syndrome or early Relapsing–Remitting-MS) is a prospective cohort study in patients with clinically isolated syndrome (CIS) or Relapsing–Remitting (RR)-MS (McDonald 2017 criteria), diagnosed within the last two years, conducted at five academic centers in Southern Germany. The collection of clinical, laboratory, imaging, and paraclinical data as well as biosamples is harmonized across centers. The primary goal is to validate (discrimination and calibration) the previously published DIFUTURE MS-Treatment Decision score (MS-TDS). The score supports clinical decision-making regarding the options of early (within 6 months after study baseline) platform medication (Interferon beta, glatiramer acetate, dimethyl/diroximel fumarate, teriflunomide), or no immediate treatment (> 6 months after baseline) of patients with early RR-MS and CIS by predicting the probability of new or enlarging lesions in cerebral magnetic resonance images (MRIs) between 6 and 24 months. Further objectives are refining the MS-TDS score and providing data to identify new markers reflecting disease course and severity. The project also provides a technical evaluation of the ProVal-MS cohort within the IT-infrastructure of the DIFUTURE consortium (Data Integration for Future Medicine) and assesses the efficacy of the data sharing techniques developed.
Perspective
Clinical cohorts provide the infrastructure to discover and to validate relevant disease-specific findings. A successful validation of the MS-TDS will add a new clinical decision tool to the armamentarium of practicing MS neurologists from which newly diagnosed MS patients may take advantage. |
| Citation: |
Bayas, Antonios and Mansmann, Ulrich and Ön, Begum I. and Hoffmann, Verena S. and Berthele, Achim and Mühlau, Mark and Kowarik, Markus C. and Krumbholz, Markus and Senel, Makbule and Steuerwald, Verena and Naumann, Markus and Hartberger, Julia and Kerschensteiner, Martin and Oswald, Eva and Ruschil, Christoph and Ziemann, Ulf and Tumani, Hayrettin and Vardakas, Ioannis and Albashiti, Fady and Kramer, Frank and Soto-Rey, Inaki and Spengler, Helmut and Mayer, Gerhard and Kestler, Hans A. and Kohlbacher, Oliver and Hagedorn, Marlien and Boeker, Martin and Kuhn, Klaus and Buchka, Stefan and Kohlmayer, Florian and Kirschke, Jan S. and Behrens, Lars and Zimmermann, Hanna and Bender, Benjamin and Sollmann, Nico and Havla, Joachim and Hemmer, Bernhard and ProVal-MS study group
(2024)
Prospective study validating a multidimensional treatment decision score predicting the 24-month outcome in untreated patients with clinically isolated syndrome and early relapsing–remitting multiple sclerosis, the ProVal-MS study.
Neurological Research and Practice, 6, Art.: 15, Paper / Clinical Trial Protocol.
ISSN 2524-3489
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