Pala Andrej, Nadji-Ohl Minou, Faust Katharina, Rückriegel Stefan, Roder Constantin, von der Brelie Christian, Forster Marie-Therese, Löbel Franziska, Schommer Stefan, Löhr Mario, Renovanz Mirjam, Grübel Nadja, Rothenbacher Dietrich, König Ralph, Engelke Jens, Schmitz Bernd, Wirtz Christian Rainer, Ringel Florian, Senft Christian, Rohde Veit, Tatagiba Marcos, Ernestus Ralf Ingo, Vajkoczy Peter, Ganslandt Oliver, Nagel Gabriele, Coburger Jan
Department of Neurosurgery, University of Ulm, Ludwig Heilmeyerstr, Günzburg, Germany.
Department of Neurosurgery, Katharinenhospital Stuttgart, Kriegsbergstr, Stuttgart, Germany.
J Neurol Surg A Cent Eur Neurosurg. 2020 Jan;81(1):48-57. doi: 10.1055/s-0039-1693650. Epub 2019 Sep 24.
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.
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.
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.
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.
NCT02686229 Clinical trials.
世界卫生组织（WHO）二级成人低级别胶质瘤（LGG）较为罕见，患者的平均总生存期（OS）相对较长。关于影响肿瘤发生和进展因素的流行病学数据稀缺，且仍缺乏手术治疗的前瞻性数据。由于LGG存在分子异质性，任何临床和流行病学研究都需要进行全面的分子特征分析。此外，作为确定疾病进展的唯一既定客观标准，需要进行详细的影像学评估。影像学和分子评估都必须标准化，以产生可比数据。该登记处的目的是通过建立一个以手术和临床为重点、包括强制性生物样本库的多中心登记处，来改善LGG患者手术治疗的证据。
LoG-Glio项目是一项前瞻性全国观察性多中心登记研究，于2015年11月1日开始。纳入标准包括所有年龄大于18岁、影像学怀疑为LGG的患者。患有可能干扰其知情同意的严重神经或精神疾病的患者，或无法进行进一步随访的患者被排除。WHO四级异柠檬酸脱氢酶（IDH）野生型胶质母细胞瘤的诊断导致患者被二次排除。除人口统计学数据外，还收集欧洲癌症研究与治疗组织脑肿瘤患者生活质量问卷附加版以及术前、术后和定期随访期间的国立卫生研究院卒中量表结果。在每个时间点都要详细记录手术和辅助治疗情况。影像学评估包括三维（3D）采集T1、液体衰减反转恢复序列和T2序列。作为最终评估的一部分，对肿瘤样本进行中心详细的神经病理学和分子评估以及对影像集进行影像学评估是研究方案的内容。
我们报告了LoG-Glio登记的前100例连续患者。3例患者因失访退出。在其余招募的患者中，8例被归类为观察等待；89例接受了手术。根据先前描述的纳入标准，70例患者患有IDH突变型胶质瘤，10例患有其他罕见的LGG，8例患者患有IDH野生型WHO二级或三级胶质瘤。
LoG-Glio登记处已成功实施。应用的选择标准导致了一个适当平衡的患者队列。预计将获得关于流行病学的短期结果数据以及当前手术技术和辅助治疗对患者预后的影响。从长远来看，该登记处的目的是验证基于分子的新WHO分类以及切除范围对无进展生存期和总生存期的影响。该登记处为未来使LGG患者受益的研究项目提供了一个开放平台。
NCT02686229临床试验
