NCT05641220Not yet recruiting
Biopsy Versus Resection in Elderly Glioblastoma Patients. A Prospective Cohort Study.
Source: ClinicalTrials.gov · Last updated 7 Dec 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 325 (estimated)
- First submitted
- 18 Nov 2022
- Start date
- 1 Jan 2023
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Erasmus Medical Center
- Diseases
- Glioblastoma
- NCT number
- NCT05641220
What you commit to
- Study type: Observational
- Planned participants: 325
- From 1 Jan 2023 to the primary completion date, 1 Jan 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous brain tumor surgery
- Previous low-grade glioma
Other illness
- Substantial non-contrast enhancing tumor areas suggesting low grade gliomas with malignant transformation
- 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.
Other
- Tumors of the cerebellum, brain stem or midline
- Multifocal contrast enhancing lesions
- Medical reasons precluding MRI (e.g. pacemaker)
- Inability to give consent as assessed by neurosurgeon (e.g. language barrier)
- Severe aphasia prohibiting neurolinguistic testing and comprehension of informed consent
Who the study is looking for
- Age ≥70 years
- 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.
- Karnofsky Performance Score (KPS) ≥70
- Written Informed consent
Age in the registry: 70 years to 95 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northwest Clinics Coordinator of this site? Confirm its status | Alkmaar | Netherlands | Unknown status |
| Medical Spectrum Twente Coordinator of this site? Confirm its status | Enschede | Netherlands | Unknown status |
| Maastricht UMC Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
| Erasmus MC Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Haaglanden MC Coordinator of this site? Confirm its status | The Hague | Netherlands | Unknown status |
| Elisabeth-TweeSteden Hospital Coordinator of this site? Confirm its status | Tilburg | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.