Glioma Microenvironment an Exploratory Study

Glioma of Brain Clinical Trial

Official title:

Glioma Microenvironment an Exploratory Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03189420
• Other study ID #: CAAE 58310716.6.0000.5461
• Status: Active, not recruiting
• Start date: October 2016
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Hospital Sirio-Libanes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Diffuse glioms are primary brain tumors characterized by infiltrative growth and high heterogeneity, which render the disease mostly incurable. Advances in genetic analysis revealed that molecular and epigenetic alterations predict patients´s overall survival and clinical outcome. However, glioma tumorigenicity is not exclusively caused by its genetic alterations. The crosstalk between tumor cells and the surrounding microenvironment plays a crucial role in modulating glioma growth and aggressiveness. In this sense, to understand the tumor microenvironment would elucidate potential treatment alternatives. The focus will be to evaluate myeloid cells and cytokines levels.

Description:

The proposal is to study gene expression and early epigenetic changes in myeloid cells from brain tumors and co-culture experiments. Tough RNA-seq, ATAC-seg and subsequent analysis to monitor the differential gene expression through different time points followed by stimuli. The study will compare the obtained results with sequencing data from microglia of full-fledged human tumor samples (glioblastoma and low grade gliomas). Additionally it will evaluated the immunologic characteristic of the tumor through cytokines levels analysis (TNF-α, IL-4, IL-6, IL-8, IL-10, IL-13, IFN-γ, TGF-β e IL-1ra).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2026
• Est. primary completion date: October 2025
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18 - 65 years old with brain tumor

• Patients that will be submitted to brain tumor ressection

Exclusion Criteria:

• Chronic neurodegenerative and inflamatory diseases

Related Conditions & MeSH terms

• Glioma
• Glioma of Brain

Intervention

Procedure:
• Tumor resection
The tumors will be resected in routine therapeutic surgeries

Locations

Country	Name	City	State
Brazil	Hospital Sirio Libanes	São Paulo	Sao

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sirio-Libanes

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Chiorean R, Berindan-Neagoe I, Braicu C, Florian IS, Leucuta D, Crisan D, Cernea V. Quantitative expression of serum biomarkers involved in angiogenesis and inflammation, in patients with glioblastoma multiforme: correlations with clinical data. Cancer Biomark. 2014;14(2-3):185-94. doi: 10.3233/CBM-130310. — View Citation

Galatro TF, Vainchtein ID, Brouwer N, Boddeke EWGM, Eggen BJL. Isolation of Microglia and Immune Infiltrates from Mouse and Primate Central Nervous System. Methods Mol Biol. 2017;1559:333-342. doi: 10.1007/978-1-4939-6786-5_23. — View Citation

Komori T. The 2016 WHO Classification of Tumours of the Central Nervous System: The Major Points of Revision. Neurol Med Chir (Tokyo). 2017 Jul 15;57(7):301-311. doi: 10.2176/nmc.ra.2017-0010. Epub 2017 Jun 8. — View Citation

Quail DF, Joyce JA. The Microenvironmental Landscape of Brain Tumors. Cancer Cell. 2017 Mar 13;31(3):326-341. doi: 10.1016/j.ccell.2017.02.009. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gene expression changes	Though RNA-seq, ATAC-seg and subsequent analysis we will be able to monitor the differential gene expression through different time points followed by stimuli.	2 years
Secondary	cytokines expression	will evaluate the immunologic characteristic of the tumor through cytokines levels analysis (TNF-a, IL-4, IL-6, IL-8, IL-10, IL-13, IFN-?, TGF-ß e IL-1ra).	2 years