GlioblastomaGLOWNCT05186064
Glioblastoma Targeted Treatment Option Maximization by WGS
A study testing whole genome sequencing in people with Glioblastoma, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
In Dutch centers performing neurosurgery on and/or treating GBM, all recurrent GBM patients are discussed in local tumor boards and this setup will be used to effectively identify possible GLOW study candidates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- whole genome sequencing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Jul 2022to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed IDH wild type glioblastoma, first recurrence after standard chemoradiation; suitable for standard-of-care re-resection;
- Age ≥ 18 years;
- Able and willing to give written informed consent;
- Life expectancy >3 months, allowing adequate follow-up of toxicity evaluation and antitumor activity;
- KPS performance status ≥70.
Who cannot join
- Currently actively treated in another antitumor clinical trial (excluding DRUP and STELLAR studies);
- Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in medication studies or which could jeopardize compliance with study requirements including, but not limited to ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness/social situations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glioblastoma Targeted Treatment Option Maximization by Whole Genome Sequencing
In Dutch centers performing neurosurgery on and/or treating GBM, all recurrent GBM patients are discussed in local tumor boards and this setup will be used to effectively identify possible GLOW study candidates. 160 patients that will undergo re-resection in the GLOW study will be presented with WGS results leading to added treatment options.
Read the detailed description
Rationale: Glioblastoma (GBM), the most common primary brain tumor, is without exception lethal. Every year 1000 patients are diagnosed with this disease in the Netherlands. Despite neurosurgery, chemo -and radiation therapy, these tumors inevitably recur. Currently, there is no gold standard at time of recurrence and treatment options are limited. In a retrospective study in two Dutch neuro-oncology centers, the overall survival (OS) for patients with recurrent GBM receiving best supportive care was 3 months, while patients receiving systemic treatment (usually nitrosurea), radiation therapy or surgery followed by systemic treatment or radiotherapy had respectively 7.3 months, 9.2 months and 11 months OS. Unfortunately, the results of dedicated trials with new drugs have been very disappointing. For those to be meaningful, extensive molecular screening is needed.
The goal of the project is to obtain the evidence for changing standard of care procedures to include extensive molecular diagnostics and consequently adapt care guidelines for this specific patient group with very poor prognosis by offering optimal and timely benefit from novel therapies, even in the absence of traditional registration trials for this small volume cancer indication.
Objective: To determine the value of and generate the clinical evidence for routine application of Whole Genome Sequencing (WGS)-based diagnostics and targeted therapy guidance for glioblastoma patients at time of first recurrence.
Study design: Prospective diagnostic multicenter cohort study Study population: Adult glioblastoma patients with recurrent disease that are undergoing resection or debulking as part of their standard care and from whom written informed consent is obtained.
Intervention: A 10 mL blood sample will be drawn once to assess each patient's germline DNA background variation that will discriminate somatic mutations from the patient's germline DNA background variations. All other interventional procedures required to perform this study are part of standard procedures.
Main study parameters/endpoints:
Primary study endpoint: Overall survival
Secondary study endpoints:
- Tumor and blood collection success rate (target >85% of all patients included)
- Number of successful WGS reports (reports for >80% of patients for which tumor material was collected)
- Number of targeted treatment options identified (at least one potentially actionable DNA alteration in >75% of patients with a WGS report)
- Number of experimental treatments available for GBM patients (relevant (off-label) drugs for at least 50% of the identified indications should be available through a study, including the Drug Rediscovery Protocol (DRUP)
- Thirty-two percent of patients starting a targeted treatment in presence of actionable variant (currently 16%)
- Conditions
- Glioblastoma
- Being tested
- whole genome sequencing
- Keywords
- first recurrence, whole genome sequencing
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole genome sequencingDiagnostic test
whole genome sequencing will be performed on tumor material after re-resection per standard of care
| Study group | Role | What they receive |
|---|---|---|
| whole genome sequencing after standard of care resection at first relapse | Experimental | Not described Receives: Diagnostic Test: whole genome sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 3 years
Secondary outcomes (2)
number targeted treatment options identified
Measured: 2 years
percent of patients starting a targeted treatment in presence of actionable variant
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start25 Jul 2022
- Primary completion30 Sep 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam University Medical Center, The Netherlands Cancer Institute, The Elisabeth-TweeSteden Hospital, Erasmus Medical Center, Medical Center Haaglanden, Isala, Leiden University Medical Center, Maastricht University Medical Center, Medisch Spectrum Twente, Radboud University Medical Center, University Medical Center Groningen
- Responsible party
- Principal investigator, Dr. F.Y.F.L. de Vos, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186064
- Sponsor's protocol ID
- NL79220.058.21 / N21.115
- Acronym
- GLOW
- Status last verified
- Jun 2026
- First submitted
- 23 Dec 2021
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Opijnen MP, Broekman MLD, de Vos FYF, Cuppen E, van der Hoeven JJM, van Linde ME, Compter A, Beerepoot LV, van den Bent MJ, Vos MJ, Fiebrich HB, Koekkoek JAF, Hoeben A, Kho KH, Driessen CML, Jeltema HR, Robe PAJT, Maas SLN. Study protocol of the GLOW study: maximising treatment options for recurrent glioblastoma patients by whole genome sequencing-based diagnostics-a prospective multicenter cohort study. BMC Med Genomics. 2022 Nov 4;15(1):233. doi: 10.1186/s12920-022-01343-4.
PubMed 36333718
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glioblastoma Targeted Treatment Option Maximization by Whole Genome Sequencing
- ClinicalTrials.gov ID
- NCT05186064
- Acronym / sponsor ID
- GLOW / NL79220.058.21 / N21.115
- Conditions
- Glioblastoma
- Keywords
- first recurrence, whole genome sequencing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Amsterdam University Medical Center, The Netherlands Cancer Institute, The Elisabeth-TweeSteden Hospital, Erasmus Medical Center, Medical Center Haaglanden, Isala, Leiden University Medical Center, Maastricht University Medical Center, Medisch Spectrum Twente, Radboud University Medical Center, University Medical Center Groningen
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 11 Jan 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.
In Dutch centers performing neurosurgery on and/or treating GBM, all recurrent GBM patients are discussed in local tumor boards and this setup will be used to effectively identify possible GLOW study candidates. 160 patients that will undergo re-resection in the GLOW study will be presented with WGS results leading to added treatment options.
Detailed description
Rationale: Glioblastoma (GBM), the most common primary brain tumor, is without exception lethal. Every year 1000 patients are diagnosed with this disease in the Netherlands. Despite neurosurgery, chemo -and radiation therapy, these tumors inevitably recur. Currently, there is no gold standard at time of recurrence and treatment options are limited. In a retrospective study in two Dutch neuro-oncology centers, the overall survival (OS) for patients with recurrent GBM receiving best supportive care was 3 months, while patients receiving systemic treatment (usually nitrosurea), radiation therapy or surgery followed by systemic treatment or radiotherapy had respectively 7.3 months, 9.2 months and 11 months OS. Unfortunately, the results of dedicated trials with new drugs have been very disappointing. For those to be meaningful, extensive molecular screening is needed.
The goal of the project is to obtain the evidence for changing standard of care procedures to include extensive molecular diagnostics and consequently adapt care guidelines for this specific patient group with very poor prognosis by offering optimal and timely benefit from novel therapies, even in the absence of traditional registration trials for this small volume cancer indication.
Objective: To determine the value of and generate the clinical evidence for routine application of Whole Genome Sequencing (WGS)-based diagnostics and targeted therapy guidance for glioblastoma patients at time of first recurrence.
Study design: Prospective diagnostic multicenter cohort study Study population: Adult glioblastoma patients with recurrent disease that are undergoing resection or debulking as part of their standard care and from whom written informed consent is obtained.
Intervention: A 10 mL blood sample will be drawn once to assess each patient's germline DNA background variation that will discriminate somatic mutations from the patient's germline DNA background variations. All other interventional procedures required to perform this study are part of standard procedures.
Main study parameters/endpoints:
Primary study endpoint: Overall survival
Secondary study endpoints:
- Tumor and blood collection success rate (target >85% of all patients included)
- Number of successful WGS reports (reports for >80% of patients for which tumor material was collected)
- Number of targeted treatment options identified (at least one potentially actionable DNA alteration in >75% of patients with a WGS report)
- Number of experimental treatments available for GBM patients (relevant (off-label) drugs for at least 50% of the identified indications should be available through a study, including the Drug Rediscovery Protocol (DRUP)
- Thirty-two percent of patients starting a targeted treatment in presence of actionable variant (currently 16%)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| whole genome sequencing after standard of care resection at first relapse | Experimental | Diagnostic Test: whole genome sequencing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histopathologically confirmed IDH wild type glioblastoma, first recurrence after standard chemoradiation; suitable for standard-of-care re-resection;
- Age ≥ 18 years;
- Able and willing to give written informed consent;
- Life expectancy >3 months, allowing adequate follow-up of toxicity evaluation and antitumor activity;
- KPS performance status ≥70.
Key exclusion criteria (2 listed)
- Currently actively treated in another antitumor clinical trial (excluding DRUP and STELLAR studies);
- Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in medication studies or which could jeopardize compliance with study requirements including, but not limited to ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness/social situations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole genome sequencingwhole genome sequencing will be performed on tumor material after re-resection per standard of care | Diagnostic test | whole genome sequencing after standard of care resection at first relapse |
Primary outcome
overall survival
Time frame: 3 years
2 secondary outcomes
number targeted treatment options identified
Time frame: 2 years
percent of patients starting a targeted treatment in presence of actionable variant
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Derived from this study: PubMed 36333718van Opijnen MP, Broekman MLD, de Vos FYF, Cuppen E, van der Hoeven JJM, van Linde ME, Compter A, Beerepoot LV, van den Bent MJ, Vos MJ, Fiebrich HB, Koekkoek JAF, Hoeben A, Kho KH, Driessen CML, Jeltema HR, Robe PAJT, Maas SLN. Study protocol of the GLOW study: maximising treatment options for recurrent glioblastoma patients by whole genome sequencing-based diagnostics-a prospective multicenter cohort study. BMC Med Genomics. 2022 Nov 4;15(1):233. doi: 10.1186/s12920-022-01343-4.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole genome sequencing in people with Glioblastoma, run by UMC Utrecht at 1 site 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05186064, which also lists 1 linked publication.
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 4 Jun 2026.