Department of Neurosurgery, Haaglanden Medical Center, The Hague, The Netherlands.
Department of Neurosurgery, Leiden University Medical Center, Leiden, The Netherlands.
BMC Med Genomics. 2022 Nov 4;15(1):233. doi: 10.1186/s12920-022-01343-4.
Glioblastoma (GBM), the most common glial primary brain tumour, is without exception lethal. Every year approximately 600 patients are diagnosed with this heterogeneous disease in The Netherlands. Despite neurosurgery, chemo -and radiation therapy, these tumours inevitably recur. Currently, there is no gold standard at time of recurrence and treatment options are limited. Unfortunately, the results of dedicated trials with new drugs have been very disappointing. The goal of the project is to obtain the evidence for changing standard of care (SOC) procedures to include whole genome sequencing (WGS) and consequently adapt care guidelines for this specific patient group with very poor prognosis by offering optimal and timely benefit from novel therapies, even in the absence of traditional registration trials for this small volume cancer indication.
The GLOW study is a prospective diagnostic cohort study executed through collaboration of the Hartwig Medical Foundation (Hartwig, a non-profit organisation) and twelve Dutch centers that perform neurosurgery and/or treat GBM patients. A total of 200 patients with a first recurrence of a glioblastoma will be included. Dual primary endpoint is the percentage of patients who receive targeted therapy based on the WGS report and overall survival. Secondary endpoints include WGS report success rate and number of targeted treatments available based on WGS reports and number of patients starting a treatment in presence of an actionable variant. At recurrence, study participants will undergo SOC neurosurgical resection. Tumour material will then, together with a blood sample, be sent to Hartwig where it will be analysed by WGS. A diagnostic report with therapy guidance, including potential matching off-label drugs and available clinical trials will then be sent back to the treating physician for discussing of the results in molecular tumour boards and targeted treatment decision making.
The GLOW study aims to provide the scientific evidence for changing the SOC diagnostics for patients with a recurrent glioblastoma by investigating complete genome diagnostics to maximize treatment options for this patient group.
ClinicalTrials.gov Identifier: NCT05186064.
胶质母细胞瘤（GBM）是最常见的神经胶质原发性脑肿瘤，无一例外地致命。每年荷兰约有 600 名患者被诊断出患有这种异质性疾病。尽管进行了神经外科手术、化疗和放疗，但这些肿瘤不可避免地会复发。目前，在复发时没有黄金标准，治疗选择有限。不幸的是，专门针对新药的试验结果非常令人失望。该项目的目标是获得证据，将标准护理（SOC）程序改变为包括全基因组测序（WGS），并通过为预后非常差的特定患者群体提供最佳和及时的新型治疗获益，从而适应护理指南，即使对于这个小体积癌症适应症，也没有传统的注册试验。
GLOW 研究是一项通过哈特威格医学基金会（Hartwig，一个非营利组织）和 12 个荷兰中心的合作进行的前瞻性诊断队列研究，这些中心进行神经外科手术和/或治疗 GBM 患者。总共将纳入 200 名初次复发的胶质母细胞瘤患者。双重主要终点是根据 WGS 报告接受靶向治疗的患者比例和总生存率。次要终点包括 WGS 报告成功率和根据 WGS 报告提供的靶向治疗数量以及存在可操作变异时开始治疗的患者数量。在复发时，研究参与者将接受 SOC 神经外科切除。然后，将肿瘤材料与血液样本一起送到 Hartwig，在那里进行 WGS 分析。然后将一份带有治疗指导的诊断报告，包括潜在的匹配标签外药物和可用的临床试验，寄回给主治医生，以便在分子肿瘤委员会讨论结果并做出靶向治疗决策。
GLOW 研究旨在通过研究全基因组诊断为复发性胶质母细胞瘤患者提供 SOC 诊断的科学依据，以最大程度地为该患者群体提供治疗选择。
ClinicalTrials.gov 标识符：NCT05186064。
