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Function and Composition of Regulatory B Cells in Participants With Glioblastoma (GBMdexaB)

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ClinicalTrials.gov Identifier: NCT04128774
Recruitment Status : Not yet recruiting
First Posted : October 16, 2019
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Mathilde Kouwenhoven, VU University Medical Center

Study Description
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Brief 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. 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 Design
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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 : November 1, 2019
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : November 1, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Drug: Dexamethasone
The case group receives dexamethasone based on the clinical indication.
GBM-control
Participants with clinical diagnosis of GBM not requiring dexamethasone treatment.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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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
Study Population
Patients with clinical diagnosis Gliobastoma
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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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

Sponsors and Collaborators
VU University Medical Center
Investigators
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Principal Investigator: Mathilde CM Kouwenhoven, MD, PhD Amsterdam UMC, location VUmc
More Information
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Publications:

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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 16, 2019
Last Verified: October 2019
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mathilde Kouwenhoven, VU University Medical Center:
Glioma
Glioblastoma
Adult
 Dexamethasone
B cells
Regulatory B cells
Additional relevant MeSH terms:
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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
Dexamethasone acetate
BB 1101
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
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action