Patient derived cell line (PDC) -based drug screening will be applied to formulate a personalized treatment approach.
Patient derived cell line (PDC) -based drug screening will be applied to formulate a personalized treatment approach. Patients will be randomized between the investigational group receiving in addition to standard histology analysis also the PDC-based drug screening and the standard group receiving only standard histology analysis. Outcome results will be compared in a randomized, interventional clinical performance study. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
240
The main devices used within the drug screening process are purchased from PerkinElmer, Liconic Instruments, BioTek and Beckman Coulter Diagnostics.
AKH Vienna, Department for Internal Medicine I, Oncology
Vienna, State of Vienna, Austria
RECRUITINGOverall survival time
Change in overall survival in patients receiving extensive diagnostic work up including the standard histology analysis and PDC- based drug screening in addition (interventional arm) compared to patients receiving only standard histology diagnostic work up (standard arm)
Time frame: From date of randomization until date of death from any cause or last follow up whichever came first, assessed up to 144 months
Feasibility of PDC-based drug screening
Number not interpretable results of the PDC-based drug screening; Number of interpretable results of the PDC-based drug screening
Time frame: From date of randomization until date of communication of the tumor board outcome, asses up to 144 months
Comparison of Quality of life measurements
Difference between the interventional and the standard arm using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ- C30) and the brain cancer specific questionnaire (QLQ-BN20). The scale is from 0 to 100, with higher values reporting better quality of life.
Time frame: From date of randomization until date of death from any cause or last follow up whichever came first, assessed up to 144 months
Comparison of neurocognitive function scale
differences in neurocognitive function between the interventional and standard arms using the Neurologic Assessment in Neuro-Oncology (NANO) scale
Time frame: From date of randomization until date of death from any cause or last follow up whichever came first, assessed up to 144 months
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