Function and Composition of Regulatory B Cells in Participants With Glioblastoma (GBMdexaB)
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| ClinicalTrials.gov Identifier: NCT04128774 |
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Recruitment Status :
Not yet recruiting
First Posted : October 16, 2019
Last Update Posted : October 19, 2020
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Glioblastoma, Adult | Drug: Dexamethasone |
| Study Type : | Observational |
| Estimated Enrollment : | 20 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | The Function and Composition of B Cells in Participants With Glioblastoma Treated With and Without Dexamethasone |
| Estimated Study Start Date : | January 1, 2021 |
| Estimated Primary Completion Date : | November 1, 2023 |
| Estimated Study Completion Date : | November 1, 2024 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Drug: Dexamethasone
The case group receives dexamethasone based on the clinical indication. |
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GBM-control
Participants with clinical diagnosis of GBM not requiring dexamethasone treatment.
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- 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.
- Changes in frequency of regulatory B cells after treatment of participants with Glioblastoma with dexamethasone [ Time Frame: Two weeks ]Changes in the frequency and functionality of regulatory B cells in blood after two weeks of treatment with dexamethasone.
- Changes in frequency of regulatory B cells in participants with Glioblastoma [ Time Frame: Two weeks ]Changes in the frequency and functionality of regulatory B cells in blood in patients not treated with dexamethasone.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
Clinical diagnosis Glioblastoma Patients are 18 years or older at first diagnosis
Exclusion Criteria:
No indication for surgery to confirm radiological diagnosis Not able or willing to give informed consent Allergy or intolerance to dexamethasone
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04128774
| Contact: Mathilde CM Kouwenhoven, MD, PhD | +31 20 4444444 | m.kouwenhoven@amsterdamumc.nl | |
| Contact: Juan JJ Vallejo, PhD | +31 20 4444444 | jj.garciavallejo@amsterdamumc.nl |
| Principal Investigator: | Mathilde CM Kouwenhoven, MD, PhD | Amsterdam UMC, location VUmc |
| Responsible Party: | Mathilde Kouwenhoven, Neurologist, VU University Medical Center |
| ClinicalTrials.gov Identifier: | NCT04128774 |
| Other Study ID Numbers: |
2019.554 CCA2018-5-50 ( Other Grant/Funding Number: Cancer Center Amsterdam Research Foundation ) NL71359.029.19 ( Registry Identifier: Nederlands Trial Register ) |
| First Posted: | October 16, 2019 Key Record Dates |
| Last Update Posted: | October 19, 2020 |
| Last Verified: | October 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | Data will be stored in coded form in a Castor database. At this moment data will not be available to other researchers. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Glioma Glioblastoma Adult |
Dexamethasone B cells Regulatory B cells |
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Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Dexamethasone |
Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |