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

Recruiting

• Conditions: Brain Tumor - Metastatic; Brain Tumor, Primary
• Interventions: Diagnostic Test: Circulating leukocytes immunophenotype; Diagnostic Test: Tumor sampling

• Registration Number: NCT05831631
• Lead Sponsor: Pietro Mortini, MD, Prof.

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

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2023-03-16
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-14
• Last Update Submitted: 2023-04-14
• Study First Posted: 2023-04-26
• Last Update Posted: 2023-04-26
• Primary Completion: 2024-07-31
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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Exclusion Criteria

• Patients who do not meet inclusion criteria.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Included patients	Circulating leukocytes immunophenotype	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.
Included patients	Tumor sampling	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.

Primary Outcome Measures

Name	Time	Method
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 leucocytes immunophenotype	After surgery (tumor sampling)	Infiltrating T-cell subpopulations (%)
Baseline tumor-infiltrating lymphocytes count	After surgery (tumor sampling)	Infiltrating lymphocytes count (10\^3/ml)

Trial Locations

Locations (1)

IRCCS San Raffaele Scientific Institute; 🇮🇹 Milan, Italy