NCT03189420

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
7mo left

Started Oct 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Oct 2016Dec 2026

Study Start

First participant enrolled

October 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

9 years

First QC Date

June 14, 2017

Last Update Submit

April 17, 2024

Conditions

Glioma of Brain

Keywords

gliomaglioblastomalow grade tumor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • cytokines expression

    2 years

Study Arms (2)

Glioblastoma

Samples of brain tumor diagnosed as glioblastoma

Procedure: Tumor resection

Low grade glioma

Samples of brain tumor diagnosed as low grade glioma

Procedure: Tumor resection

Interventions

Tumor resectionPROCEDURE

The tumors will be resected in routine therapeutic surgeries

Also known as: surgery
GlioblastomaLow grade glioma

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • years old with brain tumor
  • Patients that will be submitted to brain tumor ressection

You may not qualify if:

  • Chronic neurodegenerative and inflamatory diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sirio Libanes

São Paulo, Sao, 01308060, Brazil

Location

Related Publications (4)

  • 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.

    PMID: 28592714BACKGROUND

  • 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.

    PMID: 28063055BACKGROUND

  • 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.

    PMID: 28292436BACKGROUND

  • 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.

    PMID: 24878820BACKGROUND

MeSH Terms

Conditions

GliomaGlioblastoma

Interventions

Transurethral Resection of BladderSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueAstrocytoma

Intervention Hierarchy (Ancestors)

Urologic Surgical ProceduresUrogenital Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, PhD

Study Record Dates

First Submitted

June 14, 2017

First Posted

June 16, 2017

Study Start

October 1, 2016

Primary Completion

October 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

April 19, 2024

Record last verified: 2024-04

Locations

BR(1)