Explorative study of emerging blood biomarkers in progressive multiple sclerosis (EmBioProMS): Design of a prospective observational multicentre pilot study
Background: Defining clinical and subclinical progression in multiple sclerosis (MS) is challenging. Patient history, expanded disability status scale (EDSS), and magnetic resonance imaging (MRI) all have shortcomings and may underestimate disease dynamics. Emerging serum biomarkers such as glial fi...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2020-06-01
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| Series: | Contemporary Clinical Trials Communications |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865420300582 |
| _version_ | 1818995316078149632 |
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| author | Ahmed Abdelhak Andre Huss Alexander Stahmann Makbule Senel Markus Krumbholz Markus C. Kowarik Joachim Havla Tania Kümpfel Ingo Kleiter Isabella Wüstinger Uwe K. Zettl Margit Schwartz Romy Roesler Tim Friede Albert C. Ludolph Ulf Ziemann Hayrettin Tumani |
| author_facet | Ahmed Abdelhak Andre Huss Alexander Stahmann Makbule Senel Markus Krumbholz Markus C. Kowarik Joachim Havla Tania Kümpfel Ingo Kleiter Isabella Wüstinger Uwe K. Zettl Margit Schwartz Romy Roesler Tim Friede Albert C. Ludolph Ulf Ziemann Hayrettin Tumani |
| author_sort | Ahmed Abdelhak |
| collection | DOAJ |
| description | Background: Defining clinical and subclinical progression in multiple sclerosis (MS) is challenging. Patient history, expanded disability status scale (EDSS), and magnetic resonance imaging (MRI) all have shortcomings and may underestimate disease dynamics. Emerging serum biomarkers such as glial fibrillary acidic protein (GFAP) and neurofilament light chain (NfL) proved useful in many cross-sectional studies. However, longitudinal data on patients with progressive MS is scarce. Objectives: To assess whether the serum biomarkers GFAP and NfL might differentiate between patients with progressive vs. non-progressive disease stages and predict the disease course according to the Lublin criteria. Methods: EmBioProMS is a pilot, observational, prospective, multicentric study funded by the German Multiple Sclerosis Society (DMSG). 200 patients with MS according to the 2017 McDonald criteria and history of relapse-independent progression at any time (progressive MS, PMS), younger than 65 years, and with EDSS ≤ 6.5 will be recruited in 6 centres in Germany. At baseline, month 6, and 18, medical history, EDSS, Nine-Hole-Peg-Test (9-HPT), Timed-25-Foot-Walk-Test (T-25FW), Symbol-Digit-Modalities-Test (SDMT), serum GFAP, and NfL, MRI (at least baseline and month 18) and optional optical coherence tomography (OCT) will be performed. Disease progression before and during the study is defined by confirmed EDSS progression, increase by ≥ 20% in 9-HPT or T-25FW time. Conclusions: This longitudinal multicentre study will reveal to what extent the prediction of disease progression in patients with PMS will be improved by the analysis of serum biomarkers in conjunction with routine clinical data and neuroimaging measures. |
| first_indexed | 2024-12-20T21:11:54Z |
| format | Article |
| id | doaj.art-46666c1d554343f685ebfa50cc99b728 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-12-20T21:11:54Z |
| publishDate | 2020-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-46666c1d554343f685ebfa50cc99b7282022-12-21T19:26:30ZengElsevierContemporary Clinical Trials Communications2451-86542020-06-0118100574Explorative study of emerging blood biomarkers in progressive multiple sclerosis (EmBioProMS): Design of a prospective observational multicentre pilot studyAhmed Abdelhak0Andre Huss1Alexander Stahmann2Makbule Senel3Markus Krumbholz4Markus C. Kowarik5Joachim Havla6Tania Kümpfel7Ingo Kleiter8Isabella Wüstinger9Uwe K. Zettl10Margit Schwartz11Romy Roesler12Tim Friede13Albert C. Ludolph14Ulf Ziemann15Hayrettin Tumani16Department of Neurology & Stroke, University Hospital of Tübingen, Tübingen, Germany; Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany; Department of Neurology, University Hospital of Ulm, Ulm, GermanyDepartment of Neurology, University Hospital of Ulm, Ulm, GermanyMS Forschungs- und Projektentwicklungs-gGmbH, MS-Registry by the German MS-Society, Hanover, GermanyDepartment of Neurology, University Hospital of Ulm, Ulm, GermanyDepartment of Neurology & Stroke, University Hospital of Tübingen, Tübingen, Germany; Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, GermanyDepartment of Neurology & Stroke, University Hospital of Tübingen, Tübingen, Germany; Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, GermanyInstitute of Clinical Neuroimmunology, Ludwig-Maximilians University, Munich, GermanyInstitute of Clinical Neuroimmunology, Ludwig-Maximilians University, Munich, GermanyMarianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; St. Josef-Hospital, Department of Neurology, Ruhr-University, Bochum, GermanyMarianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, GermanyDepartment of Neurology, Neuroimmunological Section, University of Rostock, Rostock, GermanyDepartment of Neurology, Neuroimmunological Section, University of Rostock, Rostock, GermanyFachklinik für Neurologie Dietenbronn, Schwendi, GermanyDepartment of Medical Statistics, University Medical Centre Göttingen, Göttingen, GermanyDepartment of Neurology, University Hospital of Ulm, Ulm, GermanyDepartment of Neurology & Stroke, University Hospital of Tübingen, Tübingen, Germany; Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, GermanyDepartment of Neurology, University Hospital of Ulm, Ulm, Germany; Fachklinik für Neurologie Dietenbronn, Schwendi, Germany; Corresponding author. Universitäts- und Rehabilitationskliniken Ulm (RKU), Oberer Eselsberg 45, 89081, Ulm, Germany.Background: Defining clinical and subclinical progression in multiple sclerosis (MS) is challenging. Patient history, expanded disability status scale (EDSS), and magnetic resonance imaging (MRI) all have shortcomings and may underestimate disease dynamics. Emerging serum biomarkers such as glial fibrillary acidic protein (GFAP) and neurofilament light chain (NfL) proved useful in many cross-sectional studies. However, longitudinal data on patients with progressive MS is scarce. Objectives: To assess whether the serum biomarkers GFAP and NfL might differentiate between patients with progressive vs. non-progressive disease stages and predict the disease course according to the Lublin criteria. Methods: EmBioProMS is a pilot, observational, prospective, multicentric study funded by the German Multiple Sclerosis Society (DMSG). 200 patients with MS according to the 2017 McDonald criteria and history of relapse-independent progression at any time (progressive MS, PMS), younger than 65 years, and with EDSS ≤ 6.5 will be recruited in 6 centres in Germany. At baseline, month 6, and 18, medical history, EDSS, Nine-Hole-Peg-Test (9-HPT), Timed-25-Foot-Walk-Test (T-25FW), Symbol-Digit-Modalities-Test (SDMT), serum GFAP, and NfL, MRI (at least baseline and month 18) and optional optical coherence tomography (OCT) will be performed. Disease progression before and during the study is defined by confirmed EDSS progression, increase by ≥ 20% in 9-HPT or T-25FW time. Conclusions: This longitudinal multicentre study will reveal to what extent the prediction of disease progression in patients with PMS will be improved by the analysis of serum biomarkers in conjunction with routine clinical data and neuroimaging measures.http://www.sciencedirect.com/science/article/pii/S2451865420300582 |
| spellingShingle | Ahmed Abdelhak Andre Huss Alexander Stahmann Makbule Senel Markus Krumbholz Markus C. Kowarik Joachim Havla Tania Kümpfel Ingo Kleiter Isabella Wüstinger Uwe K. Zettl Margit Schwartz Romy Roesler Tim Friede Albert C. Ludolph Ulf Ziemann Hayrettin Tumani Explorative study of emerging blood biomarkers in progressive multiple sclerosis (EmBioProMS): Design of a prospective observational multicentre pilot study Contemporary Clinical Trials Communications |
| title | Explorative study of emerging blood biomarkers in progressive multiple sclerosis (EmBioProMS): Design of a prospective observational multicentre pilot study |
| title_full | Explorative study of emerging blood biomarkers in progressive multiple sclerosis (EmBioProMS): Design of a prospective observational multicentre pilot study |
| title_fullStr | Explorative study of emerging blood biomarkers in progressive multiple sclerosis (EmBioProMS): Design of a prospective observational multicentre pilot study |
| title_full_unstemmed | Explorative study of emerging blood biomarkers in progressive multiple sclerosis (EmBioProMS): Design of a prospective observational multicentre pilot study |
| title_short | Explorative study of emerging blood biomarkers in progressive multiple sclerosis (EmBioProMS): Design of a prospective observational multicentre pilot study |
| title_sort | explorative study of emerging blood biomarkers in progressive multiple sclerosis embioproms design of a prospective observational multicentre pilot study |
| url | http://www.sciencedirect.com/science/article/pii/S2451865420300582 |
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