Clinical trial NCT05831631: Characterization of Circulating and Tumor-infiltrating Immune Cells in Malignant Brain Tumors
Official title: Immunophenotype Characterization of Circulating and Tumor Infiltrating Immune Cells in Malignant Brain Tumors.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Tumor, Primary
Brain Tumor - Metastatic
Keywords: Immunophenotype
Primary and secondary brain tumor
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a diagnosis of malignant brain tumor (primary or secondary) and meeting the criteria for undergoing neurosurgical treatment (radiosurgery, stereotactic biopsy, surgery).

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

Eligibility criteria: 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 outcomes:
measure: Baseline leucocytes count
timeFrame: Baseline
measure: Baseline leucocytes immunophenotype
timeFrame: Baseline
measure: Baseline tumor-infiltrating lymphocytes count
timeFrame: After surgery (tumor sampling)
measure: Baseline tumor-infiltrating leucocytes immunophenotype
timeFrame: After surgery (tumor sampling)
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele Scientific Institute
Study officials:
affiliation: IRCCS San Raffaele Scientific Institute
name: Pietro Mortini, MD, Prof.
role: STUDY_DIRECTOR
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