Glioma: Biomolecular Aspects

Completed

• Conditions: Glioma, Malignant
• Interventions: Other: histopathological analysis; morphological and non-morphological magnetic resonance

• Registration Number: NCT05806619
• Lead Sponsor: Regina Elena Cancer Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-22
• Primary Completion: 2022-02-01
• Study Completion: 2022-09-30
• Status Verified: 2023-03
• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-03-28
• Last Update Submitted: 2023-03-28
• Study First Posted: 2023-04-10
• Last Update Posted: 2023-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with suspected glioma	histopathological analysis; morphological and non-morphological magnetic resonance	Patients at diagnosis of both sexes with suspected glioma
Patients at relapse/progression	histopathological analysis; morphological and non-morphological magnetic resonance	Patients at relapse/progression with neurosurgical reoperation indication

Primary Outcome Measures

Name	Time	Method
Correlation between MR and molecular data	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.

Trial Locations

Locations (2)

"Regina Elena" National Cancer Institute; 🇮🇹 Rome, Italy

San Giovanni Addolorata Hospital; 🇮🇹 Rom, Roma, Italy