Glioma Microenvironment an Exploratory Study

Active, not recruiting

• Conditions: Glioma of Brain
• Interventions: Procedure: Tumor resection

• Registration Number: NCT03189420
• Lead Sponsor: Hospital Sirio-Libanes

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2017-06-14
• Study First Submitted QC: 2017-06-14
• Study First Posted: 2017-06-16
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-19
• Primary Completion: 2025-10
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low grade glioma	Tumor resection	Samples of brain tumor diagnosed as low grade glioma
Glioblastoma	Tumor resection	Samples of brain tumor diagnosed as glioblastoma

Primary Outcome Measures

Name	Time	Method
gene expression changes	2 years	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.

Secondary Outcome Measures

Name	Time	Method
cytokines expression	2 years	will evaluate 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).

Trial Locations

Locations (1)

Hospital Sirio Libanes; 🇧🇷 São Paulo, Sao, Brazil