J Neurol Surg A Cent Eur Neurosurg 2020; 81(01): 048-057
DOI: 10.1055/s-0039-1693650
Original Article
Georg Thieme Verlag KG Stuttgart · New York

Multicentric Registry Study on Epidemiological and Biological Disease Profile as Well as Clinical Outcome in Patients with Low-Grade Gliomas: The LoG-Glio Project

Andrej Pala
1   Department of Neurosurgery, University of Ulm, Ludwig Heilmeyerstr, Günzburg, Germany
,
Minou Nadji-Ohl
2   Department of Neurosurgery, Katharinenhospital Stuttgart, Kriegsbergstr, Stuttgart, Germany
,
Katharina Faust
3   Department of Neurosurgery, Charité - University of Berlin, Charitéplatz, Berlin, Germany
,
Stefan Rückriegel
4   Department of Neurosurgery, University of Würzburg, Josef-Schneider-Strasse, Würzburg, Germany
,
Constantin Roder
5   Department of Neurosurgery, University of Tuebingen, Hoppe-Seyler-Strasse, Tuebingen, Germany
,
Christian von der Brelie
6   Department of Neurosurgery, University of Göttingen, Robert-Koch-Strasse, Göttingen, Germany
,
Marie-Therese Forster
7   Department of Neurosurgery, University of Frankfurt, Schleusenweg, Frankfurt am Main, Germany
,
Franziska Löbel
3   Department of Neurosurgery, Charité - University of Berlin, Charitéplatz, Berlin, Germany
,
Stefan Schommer
2   Department of Neurosurgery, Katharinenhospital Stuttgart, Kriegsbergstr, Stuttgart, Germany
,
Mario Löhr
4   Department of Neurosurgery, University of Würzburg, Josef-Schneider-Strasse, Würzburg, Germany
,
Mirjam Renovanz
5   Department of Neurosurgery, University of Tuebingen, Hoppe-Seyler-Strasse, Tuebingen, Germany
,
Nadja Grübel
1   Department of Neurosurgery, University of Ulm, Ludwig Heilmeyerstr, Günzburg, Germany
,
Dietrich Rothenbacher
8   Institute of Epidemiology and Medical Biometry, University of Ulm, Helmholzstrasse, Ulm, Germany
,
Ralph König
1   Department of Neurosurgery, University of Ulm, Ludwig Heilmeyerstr, Günzburg, Germany
,
Jens Engelke
1   Department of Neurosurgery, University of Ulm, Ludwig Heilmeyerstr, Günzburg, Germany
,
Bernd Schmitz
9   Department of Neuroradiology, University of Ulm, Ludwig Heilmeyerstr, Günzburg, Germany
,
Christian Rainer Wirtz
1   Department of Neurosurgery, University of Ulm, Ludwig Heilmeyerstr, Günzburg, Germany
,
Florian Ringel
10   Department of Neurosurgery, Universitätsmedizin Mainz, Mainz, Germany
,
Christian Senft
7   Department of Neurosurgery, University of Frankfurt, Schleusenweg, Frankfurt am Main, Germany
,
Veit Rohde
6   Department of Neurosurgery, University of Göttingen, Robert-Koch-Strasse, Göttingen, Germany
,
Marcos Tatagiba
5   Department of Neurosurgery, University of Tuebingen, Hoppe-Seyler-Strasse, Tuebingen, Germany
,
Ralf Ingo Ernestus
4   Department of Neurosurgery, University of Würzburg, Josef-Schneider-Strasse, Würzburg, Germany
,
Peter Vajkoczy
3   Department of Neurosurgery, Charité - University of Berlin, Charitéplatz, Berlin, Germany
,
Oliver Ganslandt
2   Department of Neurosurgery, Katharinenhospital Stuttgart, Kriegsbergstr, Stuttgart, Germany
,
Gabriele Nagel
8   Institute of Epidemiology and Medical Biometry, University of Ulm, Helmholzstrasse, Ulm, Germany
,
Jan Coburger
1   Department of Neurosurgery, University of Ulm, Ludwig Heilmeyerstr, Günzburg, Germany
› Author Affiliations
Trial registration NCT02686229 Clinical trials.
Further Information

Publication History

02 June 2018

03 April 2019

Publication Date:
24 September 2019 (online)

Abstract

Background World Health Organization (WHO) grade II low-grade gliomas (LGGs) in adults are rare, and patients' mean overall survival (OS) is relatively long. Epidemiological data on factors influencing tumor genesis and progression are scarce, and prospective data on surgical management are still lacking. Because of the molecular heterogeneity of LGG, a comprehensive molecular characterization is required for any clinical and epidemiological research. Further, a detailed radiologic assessment is needed as the only established objective criterion for progressive disease. Both radiologic and molecular assessments have to be standardized to produce comparable data. The aim of the registry is to improve the evidence for surgical management of LGG patients by establishing a multicenter registry with a strong surgical and clinical focus including mandatory biobanking.

Methods The LoG-Glio project is a prospective national observational multicenter registry that began on November 1, 2015. Inclusion criteria encompass all patients > 18 years of age with a radiologic suspicion of LGG. Patients with severe neurologic or psychiatric disorders that may interfere with their informed consent or if there is no possibility for further follow-up are excluded. Diagnosis of glioblastoma WHO grade IV isocitrate dehydrogenase (IDH) wild type leads to a secondary exclusion of patients. In addition to demographic data, results of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, add-on for patients with brain tumors, and National Health Institute Stroke Scale before and after surgery and during regular follow-ups are collected. At each time point a detailed recording of surgical and adjuvant treatment is performed. Radiologic assessment involves three-dimensional (3D) acquisition of T1, fluid-attenuated inversion recovery, and T2 sequences. For the final evaluation, a central detailed neuropathologic and molecular assessment of tumor samples and a radiologic evaluation of imaging sets are part of the study protocol.

Results We report the first 100 consecutively registered patients for LoG-Glio. Three patients dropped out due to loss of follow-up. Of the remaining recruited patients, 8 were classified as wait and scan; 89 had surgery. Using the inclusion criteria described previously, 70 patients had an IDH-mutated glioma, 10 had miscellaneous rare LGGs, and 8 patients had an IDH wild-type WHO grade II or III glioma.

Conclusion The LoG-Glio registry has been successfully implemented. Applied selection criteria result in an appropriately balanced patient cohort. Short-term outcome data on epidemiology as well as the influence of current surgical techniques and adjuvant treatment on patient outcomes are expected. In the long run, the aim of the registry is to validate the new molecular-based WHO classification and the influence of the extent of resection on progression-free survival and OS. The registry provides an open platform for future research projects benefiting patients with LGG.

 
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