Function and Composition of Regulatory B Cells in Participants With Glioblastoma (GBMdexaB)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04128774|
Recruitment Status : Not yet recruiting
First Posted : October 16, 2019
Last Update Posted : October 16, 2019
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|
|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|
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.
The case group receives dexamethasone based on the clinical indication.
Participants with clinical diagnosis of GBM not requiring dexamethasone treatment.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04128774
|Contact: Mathilde CM Kouwenhoven, MD, PhD||+31 20 email@example.com|
|Contact: Juan JJ Vallejo, PhD||+31 20 firstname.lastname@example.org|
|Principal Investigator:||Mathilde CM Kouwenhoven, MD, PhD||Amsterdam UMC, location VUmc|