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Active, Not Recruiting

NCT Number: NCT03189420

Glioma Microenvironment an Exploratory Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Glioma of Brain Astrocytoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Sirio Libanes

São Paulo, Sao, 01308060, Brazil

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tumor resection

Procedure

The tumors will be resected in routine therapeutic surgeries

Other names: surgery

Primary outcomes

  1. gene expression changes

    Time frame: 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 outcomes

  1. cytokines expression

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Hospital Sirio-Libanes

Other

Registry information

Important dates

Study start
2016
Primary completion
2025
Study completion
2026
First posted
Jun 16, 2017
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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