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Brief Title: Biopsy Versus Resection in Elderly Glioblastoma Patients. A Prospective Cohort Study.
Official Title: Biopsy Versus Resection in Elderly Glioblastoma Patients. A Prospective Cohort Study.
Study ID: NCT05641220
Brief Summary: 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.
Detailed Description:
Minimum Age: 70 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Northwest Clinics, Alkmaar, , Netherlands
Haaglanden MC, Den Haag, , Netherlands
Medical Spectrum Twente, Enschede, , Netherlands
Maastricht UMC, Maastricht, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
Elisabeth-TweeSteden Hospital, Tilburg, , Netherlands
Name: Arnaud J.P.E. Vincent, Prof. Dr.
Affiliation: Erasmus MC, department of neurosurgery
Role: PRINCIPAL_INVESTIGATOR