Glioma, MalignantGLIOMANCT05806619
Glioma: Biomolecular Aspects
An observational study of Glioma, Malignant, run by Regina Elena Cancer Institute at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glioma, Malignant
- What is being tested?
- histopathological analysis; morphological and non-morphological magnetic resonance
- How many people
- 150 participants
- Where
- 2 sitesItaly
- Study dates
- 22 Oct 2019to 30 Sep 2022
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with suspected glioma who have been subjected to surgery at diagnosis or recurrence
Who may be able to join
- glioma diagnosis
- have performed morphological brain MRI or not with contrast medium before surgery
- informed consent form
Who cannot join
- Patients without Magnetic Resonance were excluded
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
San Giovanni Addolorata Hospital
Rome, Roma, 00184
"Regina Elena" National Cancer Institute
Rome, 00144
About this study
Official title: Glioma: BIOMOLECULAR Aspects From Tissue to Radiomics
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.
Read more
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.
- Conditions
- Glioma, Malignant
- Being tested
- histopathological analysis; morphological and non-morphological magnetic resonance
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
histopathological analysis; morphological and non-morphological magnetic resonanceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected glioma | Patients at diagnosis of both sexes with suspected glioma Receives: Other: histopathological analysis; morphological and non-morphological magnetic resonance | |
| Patients at relapse/progression | Patients at relapse/progression with neurosurgical reoperation indication Receives: Other: histopathological analysis; morphological and non-morphological magnetic resonance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start22 Oct 2019
- Primary completion1 Feb 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma, MalignantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806619
- Sponsor's protocol ID
- RS1271/19
- Acronym
- GLIOMA
- Status last verified
- Mar 2023
- First submitted
- 28 Mar 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glioma: BIOMOLECULAR Aspects From Tissue to Radiomics
- ClinicalTrials.gov ID
- NCT05806619
- Acronym / sponsor ID
- GLIOMA / RS1271/19
- Conditions
- Glioma, Malignant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected glioma | – | Other: histopathological analysis; morphological and non-morphological magnetic resonancePatients at diagnosis of both sexes with suspected glioma |
| Patients at relapse/progression | – | Other: histopathological analysis; morphological and non-morphological magnetic resonancePatients at relapse/progression with neurosurgical reoperation indication |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with suspected glioma who have been subjected to surgery at diagnosis or recurrence
Key inclusion criteria (3 listed)
- glioma diagnosis
- have performed morphological brain MRI or not with contrast medium before surgery
- informed consent form
Key exclusion criteria (1 listed)
- Patients without Magnetic Resonance were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| histopathological analysis; morphological and non-morphological magnetic resonanceThe 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. | Other | Patients at relapse/progression, Patients with suspected glioma |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, Malignant, run by Regina Elena Cancer Institute at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between MR and molecular data (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.