Glioma Microenvironment an Exploratory Study

September 27, 2023 updated by: Raquel Chacon Ruiz Martinez, Hospital Sirio-Libanes
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao
      • São Paulo, Sao, Brazil, 01308060
        • Hospital Sírio Libanês

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients aged between 18-65 years old diagnosed with glioblastoma or low grade glioma

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Glioblastoma
Samples of brain tumor diagnosed as glioblastoma
Procedure: Tumor resection
The tumors will be resected in routine therapeutic surgeries
Other Names:
  • surgery
Low grade glioma
Samples of brain tumor diagnosed as low grade glioma
Procedure: Tumor resection
The tumors will be resected in routine therapeutic surgeries
Other Names:
  • surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Sirio-Libanes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 14, 2017

First Submitted That Met QC Criteria

June 14, 2017

First Posted (Actual)

June 16, 2017

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE 58310716.6.0000.5461

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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