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This trial is set up as a prospective observational cohort study to identify if either biopsy or resection should be the surgical modality of choice in elderly glioblastoma patients with a newly diagnosed tumor. Patients who are considered eligible for GBM resection or biopsy will be included. Through shared-decision making patients and their treating physicians will decide upon resection or biopsy. Written informed consent will be obtained. Participants will be followed for 1 year postoperative to assess potential differences in health-related quality of life and overall survival. Follow-up will consist of health-related quality of life questionaires and neurological assessment at 6 weeks, 3 months, 6 months and 12 months postoperative. Additionally Cognitive and neuro-linguistic tests will be done at 3 months postoperative. These will be compared to results pre-operative. After surgery, patients will receive standard adjuvant treatment with concomitant Temozolomide and radiation therapy, and standard follow-up. Patients in whom the diagnosis GBM is not confirmed in histological analyses will be excluded from the study. Total study duration will be 4 years, of which 3 years will comprise patient inclusion, with a follow-up duration of 1 year.
Age
70 - 95 years
Sex
ALL
Healthy Volunteers
No
Northwest Clinics
Alkmaar, Netherlands
Medical Spectrum Twente
Enschede, Netherlands
Maastricht UMC
Maastricht, Netherlands
Erasmus MC
Rotterdam, Netherlands
Haaglanden MC
The Hague, Netherlands
Elisabeth-TweeSteden Hospital
Tilburg, Netherlands
Start Date
January 1, 2023
Primary Completion Date
January 1, 2027
Completion Date
January 1, 2027
Last Updated
December 7, 2022
325
ESTIMATED participants
Lead Sponsor
Erasmus Medical Center
NCT05839379
NCT06860594
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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