Evidence map›Paper›PMID 32478196›Full record

ArticleContemporary clinical trials communications2020

Explorative study of emerging blood biomarkers in progressive multiple sclerosis (EmBioProMS): Design of a prospective observational multicentre pilot study.

Ahmed Abdelhak, Andre Huss, Alexander Stahmann, Makbule Senel, Markus Krumbholz, Markus C Kowarik, Joachim Havla, Tania Kümpfel, Ingo Kleiter, Isabella Wüstinger and 7 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05112484 (Importance of Therapeutic Monitoring of Orally Administered Disease-modifying Drugs Used in the Treatment of Multiple Sclerosis), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.7field-weighted citation impact, top 30% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05112484 unknown statusnot on this mapstarted 2024, after this paper: background citation

Importance of Therapeutic Monitoring of Orally Administered Disease-modifying Drugs Used in the Treatment of Multiple Sclerosis

TypeobservationalSponsorUniversity Hospital OstravaRan2024 to 2026Enrolled600ConditionsMultiple SclerosisArmsMeasurement of concentrations of orally-used DMDs, Genetic testing, Parameters for routine use of DMDs, Side effects of orally used DMDs
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 6 institutions in 1 country.

Ahmed AbdelhakDepartment of Neurology & Stroke, University Hospital of Tübingen, Tübingen, Germany.
Andre HussDepartment of Neurology, University Hospital of Ulm, Ulm, Germany.
Alexander StahmannMS Forschungs- und Projektentwicklungs-gGmbH, MS-Registry by the German MS-Society, Hanover, Germany.
Makbule SenelDepartment of Neurology, University Hospital of Ulm, Ulm, Germany.
Markus KrumbholzDepartment of Neurology & Stroke, University Hospital of Tübingen, Tübingen, Germany.
Markus C KowarikDepartment of Neurology & Stroke, University Hospital of Tübingen, Tübingen, Germany.
Joachim HavlaInstitute of Clinical Neuroimmunology, Ludwig-Maximilians University, Munich, Germany.
Tania KümpfelInstitute of Clinical Neuroimmunology, Ludwig-Maximilians University, Munich, Germany.
Ingo KleiterMarianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany.
Isabella WüstingerMarianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany.
Uwe K ZettlDepartment of Neurology, Neuroimmunological Section, University of Rostock, Rostock, Germany.
Margit SchwartzDepartment of Neurology, Neuroimmunological Section, University of Rostock, Rostock, Germany.
Romy RoeslerFachklinik für Neurologie Dietenbronn, Schwendi, Germany.
Tim FriedeDepartment of Medical Statistics, University Medical Centre Göttingen, Göttingen, Germany.
Albert C LudolphDepartment of Neurology, University Hospital of Ulm, Ulm, Germany.
Ulf ZiemannDepartment of Neurology & Stroke, University Hospital of Tübingen, Tübingen, Germany.
Hayrettin TumaniDepartment of Neurology, University Hospital of Ulm, Ulm, Germany.
University Children's Hospital Tübingen · DEUniversity Hospital Ulm · DEFachklinik für Neurologie Dietenbronn · DELudwig-Maximilians-Universität München · DEUniversity of Rostock · DESt. Josef-Hospital · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDefining 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.

objectivesTo 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.

methodsEmBioProMS 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.

conclusionsThis 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.

Identifiers

PMID32478196
PMCPMC7251538
OpenAlexW3026088494

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.