Immunophenotype Characterization of Circulating and Tumor Infiltrating Immune Cells in Malignant Brain Tumors.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Baseline leucocytes count
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Patients who do not meet inclusion criteria.
Outcomes
Primary Outcomes
Baseline leucocytes count
Time Frame: Baseline
Leucocytes count (10\^3/ml), total lymphocytes count (10\^3/ml)
Baseline leucocytes immunophenotype
Time Frame: Baseline
Determination of different leucocyte subpopulations (%)
Baseline tumor-infiltrating leucocytes immunophenotype
Time Frame: After surgery (tumor sampling)
Infiltrating T-cell subpopulations (%)
Baseline tumor-infiltrating lymphocytes count
Time Frame: After surgery (tumor sampling)
Infiltrating lymphocytes count (10\^3/ml)
Secondary Outcomes
No secondary outcomes reported
Investigators
Pietro Mortini, MD, Prof.
Professor
IRCCS San Raffaele