NCT05641220

Biopsy Versus Resection in Elderly Glioblastoma Patients. A Prospective Cohort Study.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 325 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 70 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma

Timeline

• Start date: 2023-01-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2022-12-07
• Last updated: 2022-12-07

Locations

6 sites across 1 country: Netherlands