GlioblastomaBIOPSYNCT05641220
Biopsy Versus Resection in Elderly Glioblastoma Patients. A Prospective Cohort Study.
An observational study of Glioblastoma, run by Erasmus Medical Center at 6 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 to 95 years
- Conditions the study is for
- Glioblastoma
- How many people
- 325 participants
- Where
- 6 sitesNetherlands
- Study dates
- 1 Jan 2023to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Adults with presumed Glioblastoma on first diagnostic MRI-scan.
Who may be able to join
- 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
Who cannot join
- Tumors of the cerebellum, brain stem or midline
- Multifocal contrast enhancing lesions
- Substantial non-contrast enhancing tumor areas suggesting low grade gliomas with malignant transformation
- 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
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- Previous brain tumor surgery
- Previous low-grade glioma
- 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 locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Arnaud J.P.E. Vincent, Prof. Dr. contact
6 sites in 1 country
Netherlands6 sites
Northwest Clinics
Alkmaar
Lesley E. Kwee, Drs., le.kwee@nwz.nl
Medical Spectrum Twente
Enschede
Kuan H. Kho, Drs., k.kho@mst.nl
Maastricht UMC
Maastricht
Koos Hovinga, Dr., koos.hovinga@mumc.nl
Erasmus MC
Rotterdam
Arnaud J.P.E. Vincent, Prof. Dr., a.vincent@erasmusmc.nl
Haaglanden MC
The Hague
Marieke L.D. Broekman, m.broekman@haaglandenmc.nl
Elisabeth-TweeSteden Hospital
Tilburg
Geert-Jan J.M. Rutten, Dr., g.rutten@etz.nl
About this study
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
- Keywords
- Glioblastoma, High grade glioma, Surgical management, Biopsy, Resection
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Defined as the time from diagnosis to the death of the patient from any cause
Measured: 12 months
The difference in mean change score of physical functioning, as measured with the EORTC QLQ-C30 physical functioning scale, between the two groups at 6 weeks and 3 months after surgery compared to mean score on baseline
Measured with the European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-C30), a higher scores means a worse outcome. We assume a minimally important difference of 7 between the 2 groups.
Measured: 6 weeks and 3 months after surgery
Secondary outcomes (8)
Progression-free survival (PFS), defined as the time from diagnosis to disease progression
Increase in residual tumor volume of more than 25%, or occurrence of a new tumor lesion with a volume greater than 0.175cm3), or death. As according to the RANO criteria.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months after surgery
The difference in mean change score of physical functioning, as measured with the EORTC QLQ-C30 physical functioning scale, between the two groups at 6 months and 12 months after surgery compared to mean score on baseline.
Measured with the European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-C30), a higher scores means a worse outcome.
Measured: at 6 months and 12 months after surgery
The proportion of patients with deterioration, improvement or stable physical functioning, as measured with the EORTC QLQ-C30 physical functioning scale at 6 weeks and 3 months compared to baseline.
Measured with the European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-C30), a higher scores means a worse outcome.
Measured: 6 weeks and 3 months after surgery
Descriptive reporting of changes in the mean scores on the other health-related quality of life (HRQoL) scales at 6 weeks and 3 months after surgery.
HRQoL will be measured using the Measured with the European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life questionnaire (QLQ-C30), EORTC , EORTC brain cancer module (QLQ-BN20) and EuroQol 5 Dimensions (EQ-5D) questionnaires. A higher scores means a worse outcome.
Measured: at 6 weeks and 3 months postoperative
Proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration, improvement or stability at 6 weeks and 3 months after surgery
In which deterioration is defined as an increase of at least one point and improvement as a decrease of at least one point on the total NIHSS score compared to this score at baseline.
Measured: at 6 weeks and 3 months postoperative
Descriptive reporting of differences between the groups in cognitive and neuro-linguistic screening at 3 months compared to baseline.
as measured by the Aphasia Bedside Check (ABC), Shortened Token Test, verbal fluency (category and letter), Montreal Cognitive Assessment (MOCA) and optionally CAT-NL Picture Description and Object Naming.
Measured: 3 months postoperative
Comparison of the (S)AEs in both groups.
Measured: 6 weeks postoperative
Cost-effectiveness between the two treatments.
Measured as total intramural medical costs, for a 1 year time horizon
Measured: 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A.J.P.E. VIncent, Erasmus Medical Center
- Investigators
- Arnaud J.P.E. Vincent, Prof. Dr., Principal investigator, Erasmus MC, department of neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641220
- Sponsor's protocol ID
- MEC-2022-0678
- Acronym
- BIOPSY
- Status last verified
- Nov 2022
- First submitted
- 18 Nov 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biopsy Versus Resection in Elderly Glioblastoma Patients. A Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT05641220
- Acronym / sponsor ID
- BIOPSY / MEC-2022-0678
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, High grade glioma, Surgical management, Biopsy, Resection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 70 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Adults with presumed Glioblastoma on first diagnostic MRI-scan.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Tumors of the cerebellum, brain stem or midline
- Multifocal contrast enhancing lesions
- Substantial non-contrast enhancing tumor areas suggesting low grade gliomas with malignant transformation
- Medical reasons precluding MRI (e.g. pacemaker)
- Inability to give consent as assessed by neurosurgeon (e.g. language barrier)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival (OS)
Time frame: 12 months
Defined as the time from diagnosis to the death of the patient from any cause
The difference in mean change score of physical functioning, as measured with the EORTC QLQ-C30 physical functioning scale, between the two groups at 6 weeks and 3 months after surgery compared to mean score on baseline
Time frame: 6 weeks and 3 months after surgery
Measured with the European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-C30), a higher scores means a worse outcome. We assume a minimally important difference of 7 between the 2 groups.
8 secondary outcomes
Progression-free survival (PFS), defined as the time from diagnosis to disease progression
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months after surgery
The difference in mean change score of physical functioning, as measured with the EORTC QLQ-C30 physical functioning scale, between the two groups at 6 months and 12 months after surgery compared to mean score on baseline.
Time frame: at 6 months and 12 months after surgery
The proportion of patients with deterioration, improvement or stable physical functioning, as measured with the EORTC QLQ-C30 physical functioning scale at 6 weeks and 3 months compared to baseline.
Time frame: 6 weeks and 3 months after surgery
Descriptive reporting of changes in the mean scores on the other health-related quality of life (HRQoL) scales at 6 weeks and 3 months after surgery.
Time frame: at 6 weeks and 3 months postoperative
Proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration, improvement or stability at 6 weeks and 3 months after surgery
Time frame: at 6 weeks and 3 months postoperative
Descriptive reporting of differences between the groups in cognitive and neuro-linguistic screening at 3 months compared to baseline.
Time frame: 3 months postoperative
Comparison of the (S)AEs in both groups.
Time frame: 6 weeks postoperative
Cost-effectiveness between the two treatments.
Time frame: 12 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arnaud J.P.E. Vincent, Prof. Dr. contact
Arnaud J.P.E. Vincent, Prof. Dr. principal investigator
Erasmus MC, department of neurosurgery
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma, run by Erasmus Medical Center at 6 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yvette de Haan, drs (+31612594000, y.dehaan@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.