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Search / Trial NCT05641220

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

Launched by ERASMUS MEDICAL CENTER · Nov 29, 2022

Trial Information

Current as of July 06, 2025

Not yet recruiting

Keywords

Glioblastoma High Grade Glioma Surgical Management Biopsy Resection

ClinConnect Summary

This clinical trial is studying the best surgical approach for elderly patients diagnosed with glioblastoma, a type of brain tumor. Specifically, it aims to find out whether a biopsy (taking a small sample of the tumor) or a resection (removing the tumor) is more beneficial for patients aged 70 and older. Eligible participants will have a clear diagnosis of glioblastoma based on imaging tests and will be able to provide consent for the study. Together with their doctors, patients will decide on the type of surgery they will undergo.

After the surgery, participants will be followed for one year to see how their quality of life and survival are affected. They will complete questionnaires and undergo neurological tests at several points during this year to assess their health and cognitive abilities. Additionally, all patients will receive standard treatments following their surgery. It’s important to note that those with certain types of brain tumors or who cannot undergo MRI tests will not be included in this study. The trial will last four years in total, with three years dedicated to recruiting participants and one year for follow-up.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age ≥70 years
  • 2. Tumor diagnosed as glioblastoma on MRI with distinct ring-like pattern of contrast enhancement with thick irregular walls and a core area reduced signal suggestive of tumor necrosis as assessed by the surgeon.
  • 3. Karnofsky Performance Score (KPS) ≥70
  • 4. Written Informed consent
  • Exclusion Criteria:
  • 1. Tumors of the cerebellum, brain stem or midline
  • 2. Multifocal contrast enhancing lesions
  • 3. Substantial non-contrast enhancing tumor areas suggesting low grade gliomas with malignant transformation
  • 4. Medical reasons precluding MRI (e.g. pacemaker)
  • 5. Inability to give consent as assessed by neurosurgeon (e.g. language barrier)
  • 6. Severe aphasia prohibiting neurolinguistic testing and comprehension of informed consent
  • 7. Previous brain tumor surgery
  • 8. Previous low-grade glioma
  • 9. Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin.

About Erasmus Medical Center

Erasmus Medical Center, located in Rotterdam, Netherlands, is a leading academic medical center renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent institution within the Erasmus University Rotterdam, the center integrates cutting-edge scientific inquiry with comprehensive patient care, focusing on a wide range of medical specialties. With a strong emphasis on multidisciplinary collaboration, Erasmus Medical Center aims to translate research findings into tangible clinical applications, enhancing treatment options and improving patient outcomes. The institution is dedicated to conducting ethical and rigorous clinical trials that contribute to the global body of medical knowledge and foster advancements in personalized medicine.

Locations

Rotterdam, , Netherlands

Maastricht, , Netherlands

Enschede, , Netherlands

Den Haag, , Netherlands

Rotterdam, Zuid Holland, Netherlands

Alkmaar, , Netherlands

Tilburg, , Netherlands

Patients applied

0 patients applied

Trial Officials

Arnaud J.P.E. Vincent, Prof. Dr.

Principal Investigator

Erasmus MC, department of neurosurgery

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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