Using the molecular classification of glioblastoma to inform personalized treatment.
Adriana Olar, Kenneth D Aldape
https://pubmed.ncbi.nlm.nih.gov/24114756Actively Recruiting
Age: 18Years +
All Genders
ID05831631
Immunophenotype Characterization of Circulating and Tumor Infiltrating Immune Cells in Malignant Brain Tumors
Led by Pietro Mortini, MD, Prof. · Updated on 2025-06-11
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study the immune cells in patients with malignant brain tumors, including primary tumors like glioblastoma multiforme and metastatic brain tumors. Researchers want to understand the types and behavior of immune cells circulating in the blood and those present within the tumor. The goal is to see how these immune profiles relate to cancer outcomes, which may help improve understanding of these aggressive brain cancers. The study involves collecting blood samples before neurosurgical treatment and at several follow-up times: 3, 6, 9, and 12 months after surgery. Tumor samples obtained during surgery will also be analyzed to study immune T cells inside the tumor. The blood samples will be tested using flow cytometry to classify leukocyte subtypes and immune profiles, while tumor samples will undergo immunohistochemical analysis to examine immune cell distribution. Participants will provide blood samples before surgery and during follow-up visits for up to one year. Researchers will measure the count and type of leukocytes and tumor-infiltrating lymphocytes at baseline and after surgery. The study will monitor changes in immune cells over time and correlate these findings with patients' clinical progression. This is a prospective observational study involving about 200 adult patients undergoing neurosurgical treatment for malignant brain tumors.
CONDITIONS
Brief Title
Characterization of Circulating and Tumor-infiltrating Immune Cells in Malignant Brain Tumors
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients (≥18 years)
- Able to express informed consent
- With primary or secondary malignant brain tumor
- Requiring neurosurgical treatment (radiosurgery, stereotactic biopsy, surgery)
You will not qualify if you...
- Patients who do not meet inclusion criteria.
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Baseline (before and during surgery)
Participants undergo blood sampling and tumor sampling during neurosurgical procedures to characterize immune cells in blood and tumors.
1 visit (in-person) including surgery and sample collection
Long-term Monitoring
Duration - Up to 12 months
Participants have blood samples collected at multiple time-points to monitor changes in circulating immune cells during disease progression and after treatment.
Visits at 3, 6, 9, and 12 months after surgery
Trial Site Locations
Total: 1 location
1
IRCCS San Raffaele Scientific Institute
Milan, Milan, Italy, 20132
Actively Recruiting
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Research Team
L
Laura Sincinelli
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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