Glioma: Biomolecular Aspects
GLIOMA
Glioma: BIOMOLECULAR Aspects From Tissue to Radiomics
1 other identifier
observational
150
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2019
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedFirst Submitted
Initial submission to the registry
March 28, 2023
CompletedFirst Posted
Study publicly available on registry
April 10, 2023
CompletedApril 10, 2023
March 1, 2023
2.3 years
March 28, 2023
March 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Patients with suspected glioma
Patients at diagnosis of both sexes with suspected glioma
Patients at relapse/progression
Patients at relapse/progression with neurosurgical reoperation indication
Interventions
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.
Eligibility Criteria
Patients with suspected glioma who have been subjected to surgery at diagnosis or recurrence
You may qualify if:
- glioma diagnosis
- have performed morphological brain MRI or not with contrast medium before surgery
- informed consent form
You may not qualify if:
- Patients without Magnetic Resonance were excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
San Giovanni Addolorata Hospital
Rome, Roma, 00184, Italy
"Regina Elena" National Cancer Institute
Rome, 00144, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 36 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2023
First Posted
April 10, 2023
Study Start
October 22, 2019
Primary Completion
February 1, 2022
Study Completion
September 30, 2022
Last Updated
April 10, 2023
Record last verified: 2023-03