Biopsy Versus Resection in Elderly Glioblastoma Patients. A Prospective Cohort Study.
NCT ID: NCT05641220
Last Updated: 2022-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
325 participants
OBSERVATIONAL
2023-01-01
2027-01-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Biopsy
Newly diagnosed elderly (\>70 years of age) glioblastoma patients who undergo biopsy
No interventions assigned to this group
Resection
Newly diagnosed elderly (\>70 years of age) glioblastoma patients who undergo resection
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
70 Years
95 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
Responsible Party
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A.J.P.E. VIncent
Prof. Dr.
Principal Investigators
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Arnaud J.P.E. Vincent, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Erasmus MC, department of neurosurgery
Locations
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Northwest Clinics
Alkmaar, , Netherlands
Medical Spectrum Twente
Enschede, , Netherlands
Maastricht UMC
Maastricht, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Haaglanden MC
The Hague, , Netherlands
Elisabeth-TweeSteden Hospital
Tilburg, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MEC-2022-0678
Identifier Type: -
Identifier Source: org_study_id
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