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OpenTrials
Completed

NCT Number: NCT05806619

Glioma: Biomolecular Aspects

Main limitations in Glioma studies are due to the wide heterogeneity and genetic instability of the tumor and to the fact that the molecular informations are static, i.e. obtained on the tumor at its onset. Instead, spontaneous or therapy-induced variations are difficult to evaluate and they would need further sampling of the tumor throughout the clinical history. Currently these data are more and more routinely used not only for diagnostics but also in the clinical management of the patient.

Furthermore, microenvironment study is becoming increasingly important. It is also important correlate morpho-functional pathway and brain Magnetic Resonance.

Therefore, the main goal of the study is to correlate the data obtained with morphological (site, signal intensity, margins, behavior after contrast medium infusion, mismatch between T2 and FLAIR sequences) and non-morphological MR imaging through a radiomic approach and Diffusion and Perfusion study, with molecular data relating to the IDH mutation, MGMT gene promoter methylation, 1p/19q co-deletion and EGFRvIII expression.

Furthermore, it is proposed to carry out a correlation between the radiological data and the mutations found in the NGS panel.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

San Giovanni Addolorata Hospital, Rome, Roma, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • glioma diagnosis
  • have performed morphological brain MRI or not with contrast medium before surgery
  • informed consent form

Exclusion criteria

  • Patients without Magnetic Resonance were excluded

Treatment and study plan

histopathological analysis; morphological and non-morphological magnetic resonance

Other

The surgical material removed during surgery was subjected to histological analysis. Morphological and non-morphological magnetic resonance examination before the neurosurgical surgery, according to clinical practice.

Primary outcomes

  1. Correlation between MR and molecular data

    Time frame: 24 months

    Demonstrate the existence of a correlation between the non-morphological brain Magnetic Resonance (MR) data obtained with diffusion and perfusion techniques and molecular data, in particular with MGMT gene methylation.

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Registry information

Official study title

Glioma: BIOMOLECULAR Aspects From Tissue to Radiomics

Acronym: GLIOMA

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 10, 2023
Registry last updated
Apr 10, 2023

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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