10.6084/M9.FIGSHARE.C.6284270.V1
Mark P. van Opijnen
Mark P.
van Opijnen
Leiden University Medical Center
Medisch Centrum Haaglanden
Marike L. D. Broekman
Marike L. D.
Broekman
Leiden University Medical Center
Medisch Centrum Haaglanden
Filip Y. F. de Vos
Filip Y. F.
de Vos
0000-0002-9082-5991
University Medical Center Utrecht
Edwin Cuppen
Edwin
Cuppen
Hartwig Medical Foundation
University Medical Center Utrecht
Jacobus J. M. van der Hoeven
Jacobus J. M.
van der Hoeven
Radboud University Nijmegen Medical Centre
Hartwig Medical Foundation
Myra E. van Linde
Myra E.
van Linde
Amsterdam University Medical Centers
Annette Compter
Annette
Compter
Antoni van Leeuwenhoek Hospital
Laurens V. Beerepoot
Laurens V.
Beerepoot
Elisabeth-TweeSteden Ziekenhuis
Martin J. van den Bent
Martin J.
van den Bent
Erasmus MC
Maaike J. Vos
Maaike J.
Vos
Medisch Centrum Haaglanden
Helle-Brit Fiebrich
Helle-Brit
Fiebrich
Isala
Johan A. F. Koekkoek
Johan A. F.
Koekkoek
Leiden University Medical Center
Medisch Centrum Haaglanden
Ann Hoeben
Ann
Hoeben
Maastricht University Medical Centre
Kuan H. Kho
Kuan H.
Kho
Medisch Spectrum Twente
University of Twente
Chantal M. L. Driessen
Chantal M. L.
Driessen
Radboud University Nijmegen Medical Centre
Hanne-Rinck Jeltema
Hanne-Rinck
Jeltema
University Medical Center Groningen
Pierre A. J. T. Robe
Pierre A. J. T.
Robe
University Medical Center Utrecht
Sybren L. N. Maas
Sybren L. N.
Maas
Leiden University Medical Center
University Medical Center Utrecht
Study protocol of the GLOW study: maximising treatment options for recurrent glioblastoma patients by whole genome sequencing-based diagnostics—a prospective multicenter cohort study
Abstract Background 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. Methods 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. Discussion 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. Trial registration: ClinicalTrials.gov Identifier: NCT05186064.
Medicine
Pharmacology
Biotechnology
69999 Biological Sciences not elsewhere classified
Cancer
Science Policy
110309 Infectious Diseases
figshare
2022
2022-11-05
2022-11-05
Collection
10.1186/s12920-022-01343-4
10.6084/m9.figshare.c.6284270
CC BY 4.0