Glioblastoma (GBM)
Conditions
Brief summary
Patients will receive in addition to standard histology analysis also the PDC- based drug screening.
Detailed description
Patients will receive in addition to standard histology analysis also the PDC- based drug screening. The PDC-based drug screening will be performed only in accordance with the approved Performance Study Plan on subjects who have signed an informed consent form. Execution of the PDC-based drug screening is limited to the approved study investigators. Based on the results of the PDC-based drug screening, a molecular tumor board will formulate a personalized treatment approach. The personalized treatment recommendation will be communicated to the patient. Application of adjuvant / maintenance therapy will be evaluated to evaluate the proportion of patients scheduled for a reduced course of radio(-chemo)therapy fit enough to receive at least one day of systemic therapy.
Interventions
DIAGNOSTIC_TESTCBmed drug screening platform
The main devices used within the drug screening process are purchased from PerkinElmer, Liconic Instruments, BioTek and Beckman Coulter Diagnostics
Sponsors
Medical University of Vienna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* ECOG performance status 0-2 * Newly diagnosed glioblastoma, IDH-wildtype - according to the 2021 WHO classification of Tumors of the Central Nervous System * Unmethylated MGMT promotor per local assessment * Successful PDC establishment and PDCs available for drug screening - based on inclusion in one of the following studies: (EK Nrs. (a) Medical University of Graz: 32-650 ex 19/20; (b) Medical University of Vienna: 1407/2021; (c) Karl Landsteiner University of Health Sciences: GS1-EK-4/823-2022; (d) Kepler University Hospital Linz: 1323/2022; (e) Medical University of Innsbruck 1003/2023) and follow-up ethics covering the establishment of an Austrian GlioBank (EK Nrs. (a) Medical University of Graz: 36-253 ex 23/24; (b) Medical University of Vienna: 2186/2023; (c) Karl Landsteiner University of Health Sciences: GS3-EK-1/211-2024; (d) Kepler University Hospital Linz: 1002/2024; (e) Medical University of Innsbruck 1095/2024) * Scheduled short-course radiotherapy with or without concomitant temozolomide * Written informed consent * No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients | From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years | Percentage of patients receiving at least one day of maintenance systemic therapy in the timeframe of 4-6 weeks after completion of a short course radio(-chemo)therapy (40 Gy in 15 fractions) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PDC-based drug screening | From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years | Assess feasibility of a PDC-based drug screening approach in a multi-center study hroughout Austria and within the timeframe short course radio(-chemo)therapy (40 Gy in 15 fractions) |
| Quality of life assessment | From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years | Quality of life assessment based on verified questionnaires |
| Neurocognitive function | From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years | Assess the neurocognitive function using the NANO scale (neurological assessment in neuro- oncology) |
| Overall survival | From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years | Assess the overall survival |
| Progression free survival | From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years | Assess the progression free survival |
| Geriatric screening tools | From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years | Geriatric vulnerability will be assessed using the Geriatric-8 (G8) and Vulnerable Elders Survey 13 (VES-13) screening tools. |
Countries
Austria
Outcome results
None listed