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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	70 Years - 95 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05641220
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Erasmus Medical Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Arnaud J.P.E. Vincent, Prof. Dr.
Principal Investigator Affiliation	Erasmus MC, department of neurosurgery
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Netherlands
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Arms & Interventions

Arms

: Biopsy

Newly diagnosed elderly (>70 years of age) glioblastoma patients who undergo biopsy

: Resection

Newly diagnosed elderly (>70 years of age) glioblastoma patients who undergo resection

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.