Brain Tumor, Primary, Brain Tumor - Metastatic
Conditions
Keywords
Immunophenotype, Primary and secondary brain tumor
Brief summary
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
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
Interventions
DIAGNOSTIC_TESTCirculating leukocytes immunophenotype
Blood samples will be tested with flow cytometry in order to characterize leukocyte subpopulations and to evaluate the circulating immunophenotype
DIAGNOSTIC_TESTTumor sampling
Immunohistochemical analysis will be performed on tumor samples in order to characterize immune T cells distribution within the tumor.
Sponsors
Pietro Mortini, MD, Prof.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline leucocytes count | Baseline | Leucocytes count (10\^3/ml), total lymphocytes count (10\^3/ml) |
| Baseline leucocytes immunophenotype | Baseline | Determination of different leucocyte subpopulations (%) |
| Baseline tumor-infiltrating lymphocytes count | After surgery (tumor sampling) | Infiltrating lymphocytes count (10\^3/ml) |
| Baseline tumor-infiltrating leucocytes immunophenotype | After surgery (tumor sampling) | Infiltrating T-cell subpopulations (%) |
Countries
Italy
Contacts
Primary ContactLaura Sincinelli
Outcome results
None listed