von Navid Farassat ; Daniel Böhringer ; Sebastian Küchlin ; Fanni E. Molnár ; Anne Schwietering ; Dorina Seger ; Martin J. Hug ; Anja-Birte Knöbel ; Sabine Schneider-Fuchs ; Gabriele Ihorst ; Bettina Kathrin Wabbels ; Christina Beisse ; Focke Ziemssen ; Frank Schüttauf ; Andrea Martina Hedergott ; Theresia Ring-Mangold ; Claudia Schuart ; Armin Wolf ; Stefanie Schmickler ; Julia Biermann ; Philipp Eberwein ; Karsten Hufendiek ; Anja Eckstein ; Gabriele Gusek-Schneider ; Michael Peter Schittkowski ; Thomas Lischka ; Wolf A. Lagrèze
Clinical trials; Medical ophthalmology; OPHTHALMOLOGY; Paediatric ophthalmology
Introduction Myopia is a major cause of degenerative eye disease and increases the risk of secondary visual impairment. Mitigating its progression therefore has great potential of clinically relevant benefit as shown by using highly diluted atropine eye drops in children of Asian origin. However, limited evidence is available regarding the efficacy and safety of low-dose atropine therapy in non-Asian populations. Hence, the Low-dose AtropIne for Myopia Control in Children (AIM) study will test the efficacy and safety of 0.02% atropine vs placebo in a German population. - Methods and analysis AIM is a national, multicentre, prospective, randomised, placebo-controlled, double-blind trial with two parallel arms. The primary objective is to assess the efficacy of atropine 0.02% eyedrops for myopia control in children of Caucasian origin. The primary outcome is the change in cycloplegic refraction after 1 year of treatment (D/year). Secondary and tertiary outcome measures comprise the change in axial length (mm/year) in children treated with 0.02% atropine compared with placebo, the myopic progression of participants treated with 0.01% compared with 0.02% atropine (D/year and mm/year), and the safety profile of both 0.02% and 0.01% atropine. Furthermore, the myopic progression 1 year after cessation of therapy with 0.02% atropine will be evaluated. Inclusion criteria are an age of 8-12 years and myopia of −1 D to −6 D with an estimated annual myopia progression of ≥0.5 D. After randomisation, patients will receive either atropine 0.02% (arm A) or placebo eye drops (arm B) in the first year of treatment. In the second year, they will continue to receive atropine 0.02% (arm A) or switch to atropine 0.01% (arm B). In the third year, they will switch to placebo (arm A) or continue with atropine 0.01% (arm B). To achieve a statistical power of 80%, the calculated sample size is 300. The trial has started in October 2021 with a planned recruitment period of 18 months. - Ethics and dissemination AIM has been approved by the Central Ethics Committee of the University Medical Center Freiburg (21-1106), local ethics committees of each participating centre and the German Federal Institute for Drugs and Medical Devices (61-3910-4044659). It complies with the Declaration of Helsinki, local laws and ICH-GCP. Results and underlying data from this trial will be disseminated through peer-reviewed publications and conference presentations. - Trial registration number NCT03865160.
BMJ open London : BMJ Publishing Group, 2011 13(2023), 4, Artikel-ID e068822, Seite 1-11 Online-Ressource
von Sonja K. Eilts ; Johanna M. Pfeil ; Broder Poschkamp ; Tim Ulrich Krohne ; Nicole Eter ; Teresa Barth ; Rainer Guthoff ; Wolf A. Lagrèze ; Milena Grundel ; Marie-Christine Bründer ; Martin Busch ; Jayashree Kalpathy-Cramer ; Michael F. Chiang ; R. V. Paul Chan ; Aaron S. Coyner ; Susan Ostmo ; Peter Campbell ; Andreas Stahl ; Stefan Schrader
von Paul Van de Heyning ; Peter Roland ; Luis Lassaletta ; Sumit Agrawal ; Marcus Atlas ; Wolf-Dieter Baumgartner ; Kevin Brown ; Marco Caversaccio ; Stefan Dazert ; Wolfgang Gstöttner ; Rudolf Hagen ; Abdulrahman Hagr ; Greg Eigner Jablonski ; Mohan Kameswaran ; Vladislav Kuzovkov ; Martin Leinung ; Yongxin Li ; Andreas German Loth ; Astrid Magele ; Robert Arndt Mlynski ; Joachim Mueller ; Lorne Parnes ; Andreas Daniel Radeloff ; Javier Gavilán
von Timo Stöver ; Stefan Dazert ; Stefan K.-R. Plontke ; Sabine Maria Kramer ; Petra Ambrosch ; Christoph Arens ; Christian Stephan Betz ; Dirk Beutner ; Christopher Bohr ; Karl-Ludwig Bruchhage ; Martin Canis ; Andreas Dietz ; Orlando Guntinas-Lichius ; Rudolf Hagen ; Werner Hosemann ; Heinrich Iro ; Jens Peter Klußmann ; Andreas Knopf ; Stephan Lang ; Martin Leinung ; Thomas Lenarz ; Hubert Martin Löwenheim ; Christoph Matthias ; Robert Arndt Mlynski ; Heidi Olze ; Jonas Jae-Hyun Park ; Peter K. Plinkert ; Andreas Daniel Radeloff ; Nicole Rotter ; Claudia Rudack ; Alessandro Bozzato ; Jörg H. Schipper ; Martin Schrader ; Patrick Schuler ; Sebastian Strieth ; Boris Stuck ; Stefan Volkenstein ; Martin Westhofen ; Gregor Wolf ; Barbara Wollenberg ; Thomas Zahnert ; Johannes Zenk ; Thomas K. Hoffmann
von Timo Stöver ; Stefan Dazert ; Thomas K. Hoffmann ; Stefan K.-R. Plontke ; Petra Ambrosch ; Christoph Arens ; Christian Stephan Betz ; Dirk Beutner ; Christopher Bohr ; Karl-Ludwig Bruchhage ; Martin Canis ; Andreas Dietz ; Orlando Guntinas-Lichius ; Rudolf Hagen ; Werner Hosemann ; Heinrich Iro ; Jens Peter Klußmann ; Andreas Knopf ; Sabine Maria Kramer ; Stephan Lang ; Martin Leinung ; Thomas Lenarz ; Hubert Martin Löwenheim ; Christoph Matthias ; Robert Arndt Mlynski ; Heidi Olze ; Jonas Jae-Hyun Park ; Peter K. Plinkert ; Andreas Daniel Radeloff ; Nicole Rotter ; Claudia Rudack ; Alessandro Bozzato ; Jörg H. Schipper ; Martin Schrader ; Sebastian Strieth ; Boris Stuck ; Stefan Volkenstein ; Martin Westhofen ; Gregor Wolf ; Barbara Wollenberg ; Thomas Zahnert ; Johannes Zenk
von David Capper ; David T. W. Jones ; Daniel Schrimpf ; Dominik Sturm ; Christian Kölsche ; Felix Sahm ; David Reuss ; Annekathrin Kratz ; Annika K. Wefers ; Kristin Huang ; Kristian Wilfried Pajtler ; Leonille Schweizer ; Damian Stichel ; Florian Selt ; Hendrik Witt ; Till Milde ; Olaf Witt ; Wolfram Scheurlen ; Christoph Geisenberger ; Stefanie Brehmer ; Marcel Seiz-Rosenhagen ; Daniel Hänggi ; Andreas Kulozik ; Axel Benner ; Martin Bendszus ; Jürgen Debus ; Michael Platten ; Andreas Unterberg ; Wolfgang Wick ; Marcel Kool ; Christel Herold-Mende ; Andreas von Deimling ; Stefan Pfister ; Hermann L. Müller
Accurate pathological diagnosis is crucial for optimal management of patients with cancer. For the approximately 100 known tumour types of the central nervous system, standardization of the diagnostic process has been shown to be particularly challenging—with substantial inter-observer variability in the histopathological diagnosis of many tumour types. Here we present a comprehensive approach for the DNA methylation-based classification of central nervous system tumours across all entities and age groups, and demonstrate its application in a routine diagnostic setting. We show that the availability of this method may have a substantial impact on diagnostic precision compared to standard methods, resulting in a change of diagnosis in up to 12% of prospective cases. For broader accessibility, we have designed a free online classifier tool, the use of which does not require any additional onsite data processing. Our results provide a blueprint for the generation of machine-learning-based tumour classifiers across other cancer entities, with the potential to fundamentally transform tumour pathology.
Nature London [u.a.] : Nature Publ. Group, 1869 555(2018), 7697, Seite 469-474 Online-Ressource
von Maximilian von Laffert ; Peter Schirmacher ; Arne Warth ; W. Weichert ; R. Büttner ; R. M. Huber ; J. Wolf ; Frank Griesinger ; M. Dietel ; C. Grohé
The EML4-ALK pathway plays an important role in a significant subset of non-small cell lung cancer patients. Treatment options such as ALK tyrosine kinase inhibitors lead to improved progression free survival and overall survival. These therapeutic options are chosen on the basis of the identification of the underlying genetic signature of the EML-ALK translocation. Efficient and easily accessible testing tools are required to identify eligible patients in a timely fashion. While FISH techniques are commonly used to detect this translocation, the broad implementation of this type of ALK testing into routine diagnostics is not optimal due to technical, structural and financial reasons. Immunohistochemical techniques to screen for EML4-ALK translocations may therefore play an important role in the near future. This consensus paper provides recommendations for the test algorithm and quality of the respective test approaches, which are discussed in the light of the current literature.
Lung cancer Amsterdam [u.a.] : Elsevier, 1985 103(2017), Seite 1-5 Online-Ressource
von Renke Lühken ; Christina Czajka ; Sonja Steinke ; Jonas Schmidt-Chanasit ; Wolf Peter Pfitzner ; Norbert Becker ; Ellen Kiel ; Andreas Krüger ; Egbert Tannich
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