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NCT Number: NCT05831631

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

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.

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Key information

Conditions

Brain Tumor, Primary Brain Diseases Brain Neoplasms Brain Tumor - Metastatic Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS San Raffaele Scientific Institute

Milan, 20132, Italy

Location status: Recruiting

Location contact

Laura Sincinelli

CONTACT

[email protected]

003926435568

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Circulating leukocytes immunophenotype

Diagnostic Test

Blood samples will be tested with flow cytometry in order to characterize leukocyte subpopulations and to evaluate the circulating immunophenotype

Tumor sampling

Diagnostic Test

Immunohistochemical analysis will be performed on tumor samples in order to characterize immune T cells distribution within the tumor.

Primary outcomes

  1. Baseline leucocytes count

    Time frame: Baseline

    Leucocytes count (10^3/ml), total lymphocytes count (10^3/ml)

  2. Baseline leucocytes immunophenotype

    Time frame: Baseline

    Determination of different leucocyte subpopulations (%)

  3. Baseline tumor-infiltrating lymphocytes count

    Time frame: After surgery (tumor sampling)

    Infiltrating lymphocytes count (10^3/ml)

  4. Baseline tumor-infiltrating leucocytes immunophenotype

    Time frame: After surgery (tumor sampling)

    Infiltrating T-cell subpopulations (%)

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Sincinelli

CONTACT

[email protected]

0226435568 ext. 0039

Sponsors and collaborators

Lead sponsor

Pietro Mortini, MD, Prof.

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2029
First posted
Apr 26, 2023
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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