Characterization of Circulating and Tumor-infiltrating Immune Cells in Malignant Brain Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Included patients 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
Blood samples will be tested with flow cytometry in order to characterize leukocyte subpopulations and to evaluate the circulating immunophenotype
Diagnostic Test: Tumor sampling
Immunohistochemical analysis will be performed on tumor samples in order to characterize immune T cells distribution within the tumor.
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Outcome Measures
Primary Outcome Measures
- 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 (%)
Eligibility Criteria
Criteria
Inclusion criteria:
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Adult patients (≥18 years)
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Able to express informed consent
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With primary or secondary malignant brain tumor
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Requiring neurosurgical treatment (radiosurgery, stereotactic biopsy, surgery)
Exclusion Criteria:
- Patients who do not meet inclusion criteria.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IRCCS San Raffaele Scientific Institute | Milan | Italy | 20132 |
Sponsors and Collaborators
- Pietro Mortini, MD, Prof.
Investigators
- Study Director: Pietro Mortini, MD, Prof., IRCCS San Raffaele Scientific Institute
Study Documents (Full-Text)
None provided.More Information
Publications
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- NCH 02-2022