NCT05831631

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Pietro Mortini, MD, Prof. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Brain Tumor, Primary
• Brain Tumor - Metastatic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-01
• Primary completion: 2028-07-31
• Completion: 2029-08-01
• First posted: 2023-04-26
• Last updated: 2025-06-11

Locations

1 site across 1 country: Italy