To hear about similar clinical trials, please enter your email below
Trial Title:
Characterization of Circulating and Tumor-infiltrating Immune Cells in Malignant Brain Tumors
NCT ID:
NCT05831631
Condition:
Brain Tumor, Primary
Brain Tumor - Metastatic
Conditions: Official terms:
Neoplasms
Brain Neoplasms
Conditions: Keywords:
Immunophenotype
Primary and secondary brain tumor
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Circulating leukocytes immunophenotype
Description:
Blood samples will be tested with flow cytometry in order to characterize leukocyte
subpopulations and to evaluate the circulating immunophenotype
Arm group label:
Included patients
Intervention type:
Diagnostic Test
Intervention name:
Tumor sampling
Description:
Immunohistochemical analysis will be performed on tumor samples in order to characterize
immune T cells distribution within the tumor.
Arm group label:
Included patients
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
Criteria for eligibility:
Study pop:
Adult patients with a diagnosis of malignant brain tumor (primary or secondary) and
meeting the criteria for undergoing neurosurgical treatment (radiosurgery, stereotactic
biopsy, surgery).
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
IRCCS San Raffaele Scientific Institute
Address:
City:
Milan
Zip:
20132
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Laura Sincinelli
Phone:
003926435568
Email:
sincinelli.laura@hsr.it
Start date:
August 1, 2022
Completion date:
August 1, 2025
Lead sponsor:
Agency:
Pietro Mortini, MD, Prof.
Agency class:
Other
Source:
IRCCS San Raffaele
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05831631
