Glioblastoma, AdultGBMdexaBNCT04128774
Function and Composition of Regulatory B Cells in Participants With Glioblastoma
An observational study of Glioblastoma, Adult, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Rationale: This project elaborates on a novel finding of the investigators that has not yet been reported in literature, namely the presence of elevated levels of atypical B cells in participants with glioblastoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Adult
- What is being tested?
- Dexamethasone
- How many people
- 5 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2021to 20 Nov 2024
- Phase
- Observational
- 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
Study population: Patients with clinical diagnosis Gliobastoma
Who may be able to join
- Clinical diagnosis Glioblastoma Patients are 18 years or older at first diagnosis
Who cannot join
- No indication for surgery to confirm radiological diagnosis Not able or willing to give informed consent Allergy or intolerance to dexamethasone
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam Medical Universities
Amsterdam, North Holland, 1081HV
About this study
Official title: The Function and Composition of B Cells in Participants With Glioblastoma Treated With and Without Dexamethasone
Rationale: This project elaborates on a novel finding of the investigators that has not yet been reported in literature, namely the presence of elevated levels of atypical B cells in participants with glioblastoma. ln the period 2015 2018 the investigators analysed the blood immune subset composition of a cohort of 180 participants undergoing neurosurgery. The most relevant finding was the presence of an abnormally elevated level of B cells in the blood of the great majority of participants with glioblastoma. These B cells may be involved in the immunosuppression associated with glioblastoma that makes this tumor refractory to immunotherapy. Multiple regression analysis indicated that the increase in the frequency of atypical B cells in participants' peripheral blood was related with the administration of dexamethasone prior to surgery. However, this study design did not allow the investigators to address the causality of the relationship between dexamethasone and atypic B cell dysregulation. Alternative treatments to dexamethasone exist.
Objective: To investigate the effect of dexamethasone in the dysregulation of atypic B cells in participants with glioblastoma.
Read more
Study design: Observational case control pilot study with 20 participants (10 per group).
Study population: Newly diagnosed participants with glioblastoma. Intervention (if applicable): Observational study. Main study parameters/endpoints: Changes in the immune subset composition and functionality in the peripheral blood of participants with glioblastoma upon administration of dexamethasone for neurological signs of peritumoral edema (oral dexamethasone).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The investigators will collect blood (28 ml) during the first visit and again (28 ml) at the time of surgery (2 weeks ± 3 days). There will not be additional site visits, physical examinations or any other tests, questionnaires. Blood collection is only a minor discomfort and it does not represent any additional risk.
- Conditions
- Glioblastoma, Adult
- Being tested
- Dexamethasone
- Keywords
- Glioma, Glioblastoma, Adult, Dexamethasone, B cells, Regulatory B cells
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Dexamethasone indicated based on the clinical indication.
The case group receives dexamethasone based on the clinical indication.
| Study group | Role | What they receive |
|---|---|---|
| GBM-dexa | Participants with clinical diagnosis of GBM, that require dexamethasone due to neurological deficits. Dose is based on the clinical judgement of the treating physician but should be given at least two weeks. Dexamethasone is given once a day. Receives: Drug: Dexamethasone | |
| GBM-control | Participants with clinical diagnosis of GBM not requiring dexamethasone treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of regulatory B cells in blood of participant with Glioblastoma
ldentify if dexamethasone treatment alters the frequency and functionality of atypic B cells (CD25+CD95Fas+-B cells) in blood in GBM.
Measured: Two weeks
Secondary outcomes (2)
Changes in frequency of regulatory B cells after treatment of participants with Glioblastoma with dexamethasone
Changes in the frequency and functionality of regulatory B cells in blood after two weeks of treatment with dexamethasone.
Measured: Two weeks
Changes in frequency of regulatory B cells in participants with Glioblastoma
Changes in the frequency and functionality of regulatory B cells in blood in patients not treated with dexamethasone.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start1 Jan 2021
- Primary completion20 Nov 2024
- Study completion20 Nov 2024
Why it stopped: To few participants
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 Glioblastoma, AdultStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathilde Kouwenhoven, Amsterdam UMC, location VUmc
- Investigators
- Mathilde CM Kouwenhoven, MD, PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128774
- Sponsor's protocol ID
- 2019.554
- Other IDs
- CCA2018-5-50, NL71359.029.19
- Acronym
- GBMdexaB
- Status last verified
- Nov 2024
- First submitted
- 11 Oct 2019
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be stored in coded form in a Castor database. At this moment data will not be available to other researchers.
Publications
Dusoswa SA, Verhoeff J, Garcia-Vallejo JJ. OMIP-054: Broad Immune Phenotyping of Innate and Adaptive Leukocytes in the Brain, Spleen, and Bone Marrow of an Orthotopic Murine Glioblastoma Model by Mass Cytometry. Cytometry A. 2019 Apr;95(4):422-426. doi: 10.1002/cyto.a.23725. Epub 2019 Jan 31.
PubMed 30701669
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Function and Composition of B Cells in Participants With Glioblastoma Treated With and Without Dexamethasone
- ClinicalTrials.gov ID
- NCT04128774
- Acronym / sponsor ID
- GBMdexaB / 2019.554
- Conditions
- Glioblastoma, Adult
- Keywords
- Glioma, Glioblastoma, Adult, Dexamethasone, B cells, Regulatory B cells
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: To few participants
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 16 Oct 2019 (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.
Rationale: This project elaborates on a novel finding of the investigators that has not yet been reported in literature, namely the presence of elevated levels of atypical B cells in participants with glioblastoma. ln the period 2015 2018 the investigators analysed the blood immune subset composition of a cohort of 180 participants undergoing neurosurgery. The most relevant finding was the presence of an abnormally elevated level of B cells in the blood of the great majority of participants with glioblastoma. These B cells may be involved in the immunosuppression associated with glioblastoma that makes this tumor refractory to immunotherapy. Multiple regression analysis indicated that the increase in the frequency of atypical B cells in participants' peripheral blood was related with the administration of dexamethasone prior to surgery. However, this study design did not allow the investigators to address the causality of the relationship between dexamethasone and atypic B cell dysregulation. Alternative treatments to dexamethasone exist.
Objective: To investigate the effect of dexamethasone in the dysregulation of atypic B cells in participants with glioblastoma.
Study design: Observational case control pilot study with 20 participants (10 per group).
Study population: Newly diagnosed participants with glioblastoma. Intervention (if applicable): Observational study. Main study parameters/endpoints: Changes in the immune subset composition and functionality in the peripheral blood of participants with glioblastoma upon administration of dexamethasone for neurological signs of peritumoral edema (oral dexamethasone).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The investigators will collect blood (28 ml) during the first visit and again (28 ml) at the time of surgery (2 weeks ± 3 days). There will not be additional site visits, physical examinations or any other tests, questionnaires. Blood collection is only a minor discomfort and it does not represent any additional risk.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GBM-dexa | – | Drug: DexamethasoneParticipants with clinical diagnosis of GBM, that require dexamethasone due to neurological deficits. Dose is based on the clinical judgement of the treating physician but should be given at least two weeks. Dexamethasone is given once a day. |
| GBM-control | – | –Participants with clinical diagnosis of GBM not requiring dexamethasone treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical diagnosis Gliobastoma
Key inclusion criteria (1 listed)
- Clinical diagnosis Glioblastoma Patients are 18 years or older at first diagnosis
Key exclusion criteria (1 listed)
- No indication for surgery to confirm radiological diagnosis Not able or willing to give informed consent Allergy or intolerance to dexamethasone
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 |
|---|---|---|
| DexamethasoneAlso: Dexamethasone indicated based on the clinical indication.The case group receives dexamethasone based on the clinical indication. | Drug | GBM-dexa |
Primary outcome
Frequency of regulatory B cells in blood of participant with Glioblastoma
Time frame: Two weeks
ldentify if dexamethasone treatment alters the frequency and functionality of atypic B cells (CD25+CD95Fas+-B cells) in blood in GBM.
2 secondary outcomes
Changes in frequency of regulatory B cells after treatment of participants with Glioblastoma with dexamethasone
Time frame: Two weeks
Changes in frequency of regulatory B cells in participants with Glioblastoma
Time frame: Two weeks
Results and safety
The study was stopped early (reason given: To few participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Background: PubMed 30701669Dusoswa SA, Verhoeff J, Garcia-Vallejo JJ. OMIP-054: Broad Immune Phenotyping of Innate and Adaptive Leukocytes in the Brain, Spleen, and Bone Marrow of an Orthotopic Murine Glioblastoma Model by Mass Cytometry. Cytometry A. 2019 Apr;95(4):422-426. doi: 10.1002/cyto.a.23725. Epub 2019 Jan 31.
- Individual participant dataSharing planned: Undecided. Data will be stored in coded form in a Castor database. At this moment data will not be available to other researchers.
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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.
Mathilde CM Kouwenhoven, MD, PhD principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma, Adult, run by Amsterdam UMC, location VUmc 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 26 Nov 2024. 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 was stopped early (reason given: To few participants). Results are not available in the source record.
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?
Frequency of regulatory B cells in blood of participant with Glioblastoma (time frame: Two weeks). 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 NCT04128774, 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 26 Nov 2024.