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

Pietro Mortini, MD, Prof.

Status: Enrolling

Conditions: Brain Tumor, Primary; Brain Tumor - Metastatic

Treatments: Diagnostic Test: Tumor sampling; Diagnostic Test: Circulating leukocytes immunophenotype

Study type: Observational

Funder types: Other

Identifiers

NCT05831631

NCH 02-2022

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

Included patients

Description:

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.

Treatment:

Diagnostic Test: Circulating leukocytes immunophenotype

Diagnostic Test: Tumor sampling