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Recruiting Observational

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

NCT05831631 · tracked via the Priya Life Science Italy tracker
Sponsor
Pietro Mortini, MD, Prof
Phase
Observational
Started
2022-08-01
Last updated
2025-06-11

Condition(s) studied

Brain Tumor, PrimaryBrain Tumor - Metastatic

Investigational drug(s) / intervention(s)

Circulating leukocytes immunophenotypeTumor sampling

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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 (%)

Trial sites (1)

FacilityCityRegionStatus
IRCCS San Raffaele Scientific Institute Milan Milan Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05831631 on ClinicalTrials.gov ↗ ← All trials in Italy