Characterization of Circulating and Tumor-infiltrating Immune Cells in Malignant Brain Tumors

Study Overview
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Brief Summary
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The goal of this observational study is to characterize the circulating leukocyte profile and the immune T cells distribution within the tumor in patients with malignant brain tumors and to correlate these findings with the oncological outcome. Participants will be subjected to blood sampling before surgery and for 12 months of follow-up. Additional sampling and analysis will be performed on tumor samples.

Detailed Description
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High-grade gliomas are the most frequent type of primary brain tumor in adults, and among them, glioblastoma multiforme (GBM) is the most malignant with an associated poor prognosis. Although significant advances have been achieved in GBM biology comprehension, patients' life expectancy is still limited to 18 months. Brain metastases (BM) are the most frequent neoplasm in the CNS; it is estimated that up to 14% of all newly diagnosed cancers will soon or later metastasize into the brain. A variety of mechanisms to escape a tumor-specific T cell-mediated immune response have been identified in glioma and other cancer entities. This project is an observational, prospective, monocentric study on patients candidates for neurosurgical procedures for brain malignant tumors with additional collection of biological material. With the present study, we aim to characterize the phenotype of both circulating- and tumor-infiltrating- immune cells at the diagnosis and their changes during disease progression and after treatment in primary and secondary brain tumors. Samples will be taken at baseline (before surgery) and at time-points: 3, 6, 9, 12 months

Official Title
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Immunophenotype Characterization of Circulating and Tumor Infiltrating Immune Cells in Malignant Brain Tumors.

Conditions
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Brain Tumor, Primary, Brain Tumor - Metastatic

Intervention / Treatment
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* Diagnostic Test: Circulating leukocytes immunophenotype
* Diagnostic Test: Tumor sampling


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Adult patients (≥18 years) Able to express informed consent With primary or secondary malignant brain tumor Requiring neurosurgical treatment (radiosurgery, stereotactic biopsy, surgery) Exclusion Criteria: Patients who do not meet inclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Included patients<br>The study population will comprise 200 (two hundred) adult patients candidate to neurosurgical treatment for newly diagnosed malignant brain tumors, able to express an informed consent. | Diagnostic Test: Circulating leukocytes immunophenotype<br>* Blood samples will be tested with flow cytometry in order to characterize leukocyte subpopulations and to evaluate the circulating immunophenotype<br>Diagnostic Test: Tumor sampling<br>* Immunohistochemical analysis will be performed on tumor samples in order to characterize immune T cells distribution within the tumor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline leucocytes count | Leucocytes count (10^3/ml), total lymphocytes count (10^3/ml) | Baseline | 
| Baseline leucocytes immunophenotype | Determination of different leucocyte subpopulations (%) | Baseline | 
| Baseline tumor-infiltrating lymphocytes count | Infiltrating lymphocytes count (10^3/ml) | After surgery (tumor sampling) | 
| Baseline tumor-infiltrating leucocytes immunophenotype | Infiltrating T-cell subpopulations (%) | After surgery (tumor sampling) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunophenotype, Primary and secondary brain tumor