Brain Tumor, PrimaryNCT05831631
Characterization of Circulating and Tumor-infiltrating Immune Cells in Malignant Brain Tumors
An observational study of Brain Tumor, Primary and Brain Tumor - Metastatic, run by Pietro Mortini, MD, Prof. at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Primary, Brain Tumor - Metastatic
- What is being tested?
- Circulating leukocytes immunophenotype and Tumor sampling
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2022to 1 Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Adult patients (≥18 years)
- Able to express informed consent
- With primary or secondary malignant brain tumor
- Requiring neurosurgical treatment (radiosurgery, stereotactic biopsy, surgery)
Who cannot join
- Patients who do not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele Scientific Institute
Milan, Milan, 20132
Laura Sincinelli, 003926435568, sincinelli.laura@hsr.it
About this study
Official title: Immunophenotype Characterization of Circulating and Tumor Infiltrating Immune Cells in Malignant Brain Tumors.
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.
Read the 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
- Conditions
- Brain Tumor, Primary, Brain Tumor - Metastatic
- Being tested
- Circulating leukocytes immunophenotype, Tumor sampling
- Keywords
- Immunophenotype, Primary and secondary brain tumor
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating leukocytes immunophenotypeDiagnostic test
Blood samples will be tested with flow cytometry in order to characterize leukocyte subpopulations and to evaluate the circulating immunophenotype
Tumor samplingDiagnostic test
Immunohistochemical analysis will be performed on tumor samples in order to characterize immune T cells distribution within the tumor.
| Study group | Role | What they receive |
|---|---|---|
| Included patients | The study population will comprise 200 (two hundred) adult patients candidate to neurosurgical treatment for newly diagnosed malignant brain tumors, able to express an informed consent. Receives: Diagnostic Test: Circulating leukocytes immunophenotype; Diagnostic Test: Tumor sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline leucocytes count
Leucocytes count (10^3/ml), total lymphocytes count (10^3/ml)
Measured: Baseline
Baseline leucocytes immunophenotype
Determination of different leucocyte subpopulations (%)
Measured: Baseline
Baseline tumor-infiltrating lymphocytes count
Infiltrating lymphocytes count (10^3/ml)
Measured: After surgery (tumor sampling)
Baseline tumor-infiltrating leucocytes immunophenotype
Infiltrating T-cell subpopulations (%)
Measured: After surgery (tumor sampling)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start1 Aug 2022
- Primary completion31 Jul 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Brain Tumor, PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pietro Mortini, MD, Prof.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pietro Mortini, MD, Prof., IRCCS San Raffaele
- Investigators
- Pietro Mortini, MD, Prof., Study director, IRCCS San Raffaele Scientific Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831631
- Sponsor's protocol ID
- NCH 02-2022
- Status last verified
- Jun 2025
- First submitted
- 16 Mar 2023
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olar A, Aldape KD. Using the molecular classification of glioblastoma to inform personalized treatment. J Pathol. 2014 Jan;232(2):165-77. doi: 10.1002/path.4282.
PubMed 24114756Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.
PubMed 15758009Wang W, Shi G, Ma B, Hao X, Dong X, Zhang B. Chemotherapy for Adults with Malignant Glioma: A Systematic Review and Network Meta-Analysis. Turk Neurosurg. 2017;27(2):174-181. doi: 10.5137/1019-5149.JTN.15462-15.0.
PubMed 27337236Barnholtz-Sloan JS, Sloan AE, Davis FG, Vigneau FD, Lai P, Sawaya RE. Incidence proportions of brain metastases in patients diagnosed (1973 to 2001) in the Metropolitan Detroit Cancer Surveillance System. J Clin Oncol. 2004 Jul 15;22(14):2865-72. doi: 10.1200/JCO.2004.12.149.
PubMed 15254054Lowery FJ, Yu D. Brain metastasis: Unique challenges and open opportunities. Biochim Biophys Acta Rev Cancer. 2017 Jan;1867(1):49-57. doi: 10.1016/j.bbcan.2016.12.001. Epub 2016 Dec 6.
PubMed 27939792Kromer C, Xu J, Ostrom QT, Gittleman H, Kruchko C, Sawaya R, Barnholtz-Sloan JS. Estimating the annual frequency of synchronous brain metastasis in the United States 2010-2013: a population-based study. J Neurooncol. 2017 Aug;134(1):55-64. doi: 10.1007/s11060-017-2516-7. Epub 2017 May 31.
PubMed 28567587Kim YH, Jung TY, Jung S, Jang WY, Moon KS, Kim IY, Lee MC, Lee JJ. Tumour-infiltrating T-cell subpopulations in glioblastomas. Br J Neurosurg. 2012 Feb;26(1):21-7. doi: 10.3109/02688697.2011.584986. Epub 2011 Jun 27.
PubMed 21707245Lohr J, Ratliff T, Huppertz A, Ge Y, Dictus C, Ahmadi R, Grau S, Hiraoka N, Eckstein V, Ecker RC, Korff T, von Deimling A, Unterberg A, Beckhove P, Herold-Mende C. Effector T-cell infiltration positively impacts survival of glioblastoma patients and is impaired by tumor-derived TGF-beta. Clin Cancer Res. 2011 Jul 1;17(13):4296-308. doi: 10.1158/1078-0432.CCR-10-2557. Epub 2011 Apr 8.
PubMed 21478334Kmiecik J, Poli A, Brons NH, Waha A, Eide GE, Enger PO, Zimmer J, Chekenya M. Elevated CD3+ and CD8+ tumor-infiltrating immune cells correlate with prolonged survival in glioblastoma patients despite integrated immunosuppressive mechanisms in the tumor microenvironment and at the systemic level. J Neuroimmunol. 2013 Nov 15;264(1-2):71-83. doi: 10.1016/j.jneuroim.2013.08.013. Epub 2013 Aug 31.
PubMed 24045166Sayour EJ, McLendon P, McLendon R, De Leon G, Reynolds R, Kresak J, Sampson JH, Mitchell DA. Increased proportion of FoxP3+ regulatory T cells in tumor infiltrating lymphocytes is associated with tumor recurrence and reduced survival in patients with glioblastoma. Cancer Immunol Immunother. 2015 Apr;64(4):419-27. doi: 10.1007/s00262-014-1651-7. Epub 2015 Jan 3.
PubMed 25555571Mauldin IS, Jo J, Wages NA, Yogendran LV, Mahmutovic A, Young SJ, Lopes MB, Slingluff CL Jr, Erickson LD, Fadul CE. Proliferating CD8+ T Cell Infiltrates Are Associated with Improved Survival in Glioblastoma. Cells. 2021 Dec 1;10(12):3378. doi: 10.3390/cells10123378.
PubMed 34943886Vilarino N, Bruna J, Bosch-Barrera J, Valiente M, Nadal E. Immunotherapy in NSCLC patients with brain metastases. Understanding brain tumor microenvironment and dissecting outcomes from immune checkpoint blockade in the clinic. Cancer Treat Rev. 2020 Sep;89:102067. doi: 10.1016/j.ctrv.2020.102067. Epub 2020 Jul 7.
PubMed 32682248Mohme M, Schliffke S, Maire CL, Runger A, Glau L, Mende KC, Matschke J, Gehbauer C, Akyuz N, Zapf S, Holz M, Schaper M, Martens T, Schmidt NO, Peine S, Westphal M, Binder M, Tolosa E, Lamszus K. Immunophenotyping of Newly Diagnosed and Recurrent Glioblastoma Defines Distinct Immune Exhaustion Profiles in Peripheral and Tumor-infiltrating Lymphocytes. Clin Cancer Res. 2018 Sep 1;24(17):4187-4200. doi: 10.1158/1078-0432.CCR-17-2617. Epub 2018 Feb 14.
PubMed 29444930Gagliardi F, De Domenico P, Snider S, Roncelli F, Pompeo E, Barzaghi LR, Bulotta A, Gregorc V, Lazzari C, Cascinu S, Finocchiaro G, Mortini P. Role of stereotactic radiosurgery for the treatment of brain metastasis in the era of immunotherapy: A systematic review on current evidences and predicting factors. Crit Rev Oncol Hematol. 2021 Sep;165:103431. doi: 10.1016/j.critrevonc.2021.103431. Epub 2021 Jul 27.
PubMed 34324961
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunophenotype Characterization of Circulating and Tumor Infiltrating Immune Cells in Malignant Brain Tumors.
- ClinicalTrials.gov ID
- NCT05831631
- Acronym / sponsor ID
- NCH 02-2022
- Conditions
- Brain Tumor, Primary, Brain Tumor - Metastatic
- Keywords
- Immunophenotype, Primary and secondary brain tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Pietro Mortini, MD, Prof.University, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Included patients | – | Diagnostic Test: Circulating leukocytes immunophenotype, Diagnostic Test: Tumor samplingThe study population will comprise 200 (two hundred) adult patients candidate to neurosurgical treatment for newly diagnosed malignant brain tumors, able to express an informed consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- Adult patients (≥18 years)
- Able to express informed consent
- With primary or secondary malignant brain tumor
- Requiring neurosurgical treatment (radiosurgery, stereotactic biopsy, surgery)
Key exclusion criteria (1 listed)
- Patients who do not meet inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circulating leukocytes immunophenotypeBlood samples will be tested with flow cytometry in order to characterize leukocyte subpopulations and to evaluate the circulating immunophenotype | Diagnostic test | Included patients |
| Tumor samplingImmunohistochemical analysis will be performed on tumor samples in order to characterize immune T cells distribution within the tumor. | Diagnostic test | Included patients |
Primary outcome
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 lymphocytes count
Time frame: After surgery (tumor sampling)
Infiltrating lymphocytes count (10^3/ml)
Baseline tumor-infiltrating leucocytes immunophenotype
Time frame: After surgery (tumor sampling)
Infiltrating T-cell subpopulations (%)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Background: PubMed 24114756Olar A, Aldape KD. Using the molecular classification of glioblastoma to inform personalized treatment. J Pathol. 2014 Jan;232(2):165-77. doi: 10.1002/path.4282.
- Background: PubMed 15758009Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.
- Background: PubMed 27337236Wang W, Shi G, Ma B, Hao X, Dong X, Zhang B. Chemotherapy for Adults with Malignant Glioma: A Systematic Review and Network Meta-Analysis. Turk Neurosurg. 2017;27(2):174-181. doi: 10.5137/1019-5149.JTN.15462-15.0.
- Background: PubMed 15254054Barnholtz-Sloan JS, Sloan AE, Davis FG, Vigneau FD, Lai P, Sawaya RE. Incidence proportions of brain metastases in patients diagnosed (1973 to 2001) in the Metropolitan Detroit Cancer Surveillance System. J Clin Oncol. 2004 Jul 15;22(14):2865-72. doi: 10.1200/JCO.2004.12.149.
- Background: PubMed 27939792Lowery FJ, Yu D. Brain metastasis: Unique challenges and open opportunities. Biochim Biophys Acta Rev Cancer. 2017 Jan;1867(1):49-57. doi: 10.1016/j.bbcan.2016.12.001. Epub 2016 Dec 6.
- Background: PubMed 28567587Kromer C, Xu J, Ostrom QT, Gittleman H, Kruchko C, Sawaya R, Barnholtz-Sloan JS. Estimating the annual frequency of synchronous brain metastasis in the United States 2010-2013: a population-based study. J Neurooncol. 2017 Aug;134(1):55-64. doi: 10.1007/s11060-017-2516-7. Epub 2017 May 31.
- Background: PubMed 21707245Kim YH, Jung TY, Jung S, Jang WY, Moon KS, Kim IY, Lee MC, Lee JJ. Tumour-infiltrating T-cell subpopulations in glioblastomas. Br J Neurosurg. 2012 Feb;26(1):21-7. doi: 10.3109/02688697.2011.584986. Epub 2011 Jun 27.
- Background: PubMed 21478334Lohr J, Ratliff T, Huppertz A, Ge Y, Dictus C, Ahmadi R, Grau S, Hiraoka N, Eckstein V, Ecker RC, Korff T, von Deimling A, Unterberg A, Beckhove P, Herold-Mende C. Effector T-cell infiltration positively impacts survival of glioblastoma patients and is impaired by tumor-derived TGF-beta. Clin Cancer Res. 2011 Jul 1;17(13):4296-308. doi: 10.1158/1078-0432.CCR-10-2557. Epub 2011 Apr 8.
- Background: PubMed 24045166Kmiecik J, Poli A, Brons NH, Waha A, Eide GE, Enger PO, Zimmer J, Chekenya M. Elevated CD3+ and CD8+ tumor-infiltrating immune cells correlate with prolonged survival in glioblastoma patients despite integrated immunosuppressive mechanisms in the tumor microenvironment and at the systemic level. J Neuroimmunol. 2013 Nov 15;264(1-2):71-83. doi: 10.1016/j.jneuroim.2013.08.013. Epub 2013 Aug 31.
- Background: PubMed 25555571Sayour EJ, McLendon P, McLendon R, De Leon G, Reynolds R, Kresak J, Sampson JH, Mitchell DA. Increased proportion of FoxP3+ regulatory T cells in tumor infiltrating lymphocytes is associated with tumor recurrence and reduced survival in patients with glioblastoma. Cancer Immunol Immunother. 2015 Apr;64(4):419-27. doi: 10.1007/s00262-014-1651-7. Epub 2015 Jan 3.
- Background: PubMed 34943886Mauldin IS, Jo J, Wages NA, Yogendran LV, Mahmutovic A, Young SJ, Lopes MB, Slingluff CL Jr, Erickson LD, Fadul CE. Proliferating CD8+ T Cell Infiltrates Are Associated with Improved Survival in Glioblastoma. Cells. 2021 Dec 1;10(12):3378. doi: 10.3390/cells10123378.
- Background: PubMed 32682248Vilarino N, Bruna J, Bosch-Barrera J, Valiente M, Nadal E. Immunotherapy in NSCLC patients with brain metastases. Understanding brain tumor microenvironment and dissecting outcomes from immune checkpoint blockade in the clinic. Cancer Treat Rev. 2020 Sep;89:102067. doi: 10.1016/j.ctrv.2020.102067. Epub 2020 Jul 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pietro Mortini, MD, Prof. study director
IRCCS San Raffaele Scientific Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor, Primary and Brain Tumor - Metastatic, run by Pietro Mortini, MD, Prof. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Sincinelli (0226435568 ext. 0039, sincinelli.laura@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline leucocytes count (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05831631, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.