Health TrialsbyHealthPanel

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

ConditionsBrain Tumor, PrimaryBrain Tumor - Metastatic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPietro Mortini, MD, Prof.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥18 years)

Able to express informed consent

With primary or secondary malignant brain tumor

Requiring neurosurgical treatment (radiosurgery, stereotactic biopsy, surgery)

Disqualifiers

Patients who do not meet inclusion criteria.

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Circulating leukocytes immunophenotype

    Diagnostic test

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

  • Tumor sampling

    Diagnostic test

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Included patients2 interventions

Trial outcomes

Primary outcomes

1

Baseline leucocytes count

Leucocytes count (10\^3/ml), total lymphocytes count (10\^3/ml)

Time frame
Baseline
2

Baseline leucocytes immunophenotype

Determination of different leucocyte subpopulations (%)

Time frame
Baseline
3

Baseline tumor-infiltrating lymphocytes count

Infiltrating lymphocytes count (10\^3/ml)

Time frame
After surgery (tumor sampling)
4

Baseline tumor-infiltrating leucocytes immunophenotype

Infiltrating T-cell subpopulations (%)

Time frame
After surgery (tumor sampling)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pietro Mortini, MD, Prof.

Lead sponsor

IRCCS San Raffaele

Sponsor institution

Source ClinicalTrials.gov
Apply now