Glioma: Biomolecular Aspects

Glioma, Malignant Clinical Trial

— GLIOMA  

Official title:

Glioma: BIOMOLECULAR Aspects From Tissue to Radiomics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05806619
• Other study ID #: RS1271/19
• Status: Completed
• Start date: October 22, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: March 2023
• Source: Regina Elena Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 30, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Glioma, Malignant

Intervention

Other:
• histopathological analysis; morphological and non-morphological magnetic resonance
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.

Locations

Country	Name	City	State
Italy	San Giovanni Addolorata Hospital	Rom	Roma
Italy	"Regina Elena" National Cancer Institute	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between MR and molecular data	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.	24 months