Clinical trial · Observational
Characterization of Circulating and Tumor-infiltrating Immune Cells in Malignant Brain Tumors
Immunophenotype Characterization of Circulating and Tumor Infiltrating Immune Cells in Malignant Brain Tumors.
NCT05831631CI-TRIAL-00090839recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor - Metastatic | Brain Neoplasm | PROBABILISTIC | 0.70 |
| Brain Tumor, Primary | Primary Brain Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Circulating leukocytes immunophenotype | Diagnostic Test | — | UNRESOLVED |
| Tumor sampling | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Included patients
- description
- 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.
- interventionNames
- Diagnostic Test: Circulating leukocytes immunophenotype
- Diagnostic Test: Tumor sampling
Primary outcomes (4)
- measure
- Baseline leucocytes count
- timeFrame
- Baseline
- description
- Leucocytes count (10\^3/ml), total lymphocytes count (10\^3/ml)
- measure
- Baseline leucocytes immunophenotype
- timeFrame
- Baseline
- description
- Determination of different leucocyte subpopulations (%)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (14)
- BACKGROUNDOlar 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. PMID 24114756
- BACKGROUNDStupp 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. PMID 15758009
- BACKGROUNDWang 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. PMID 27337236
- BACKGROUNDBarnholtz-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. PMID 15254054
- BACKGROUNDLowery 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. PMID 27939792
- BACKGROUNDKromer 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. PMID 28567587
- Kim 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.