GLIOMA: Glioma: Biomolecular Aspects

Sponsor
Regina Elena Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT05806619
Collaborator
(none)
150
2
35.3
75
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: histopathological analysis; morphological and non-morphological magnetic resonance

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Glioma: BIOMOLECULAR Aspects From Tissue to Radiomics
Actual Study Start Date :
Oct 22, 2019
Actual Primary Completion Date :
Feb 1, 2022
Actual Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Patients with suspected glioma

Patients at diagnosis of both sexes with suspected glioma

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.

Patients at relapse/progression

Patients at relapse/progression with neurosurgical reoperation indication

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 San Giovanni Addolorata Hospital Rom Roma Italy 00184
2 "Regina Elena" National Cancer Institute Rome Italy 00144

Sponsors and Collaborators

  • Regina Elena Cancer Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Regina Elena Cancer Institute
ClinicalTrials.gov Identifier:
NCT05806619
Other Study ID Numbers:
  • RS1271/19
First Posted:
Apr 10, 2023
Last Update Posted:
Apr 10, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 10, 2023