Lower Grade GliomaSTRADIVARINCT06794736
STRatifying Adult DIffuse Lower-grade Gliomas Based on Their VARIed Metabolic Profiles (STRADIVARI Project)
An observational study of Lower Grade Glioma, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 4 sites in Italy.
Trial summary
The goal of this observational study is to better characterise lower-grade gliomas from a molecular and metabolic point of view, so to identify further subgroups of these tumours with different behaviour and, possibly, different treatment susceptibility. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Grade Glioma
- How many people
- 110 participants
- Where
- 4 sitesItaly
- Study dates
- 14 Nov 2024to Aug 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by brain lower grade gliomas who access Neurosurgery Department (OR, ER, outpatient clinic) at IRCCS Ospedale Galeazzi Sant'Ambrogio and Policlinico Bari, or Oncology Department at Ospedale San Paolo Bari
Who may be able to join
- Radiological diagnosis of brain tumor compatible with lower grade glioma
- Full clinical history
- Confirmed diagnosis of lower grade glioma
- Full clinical and radiological history
Who cannot join
- Current pregnancy or lactation
- Patients not able to provide informed consent
- Retrospective Cohort of FFPE samples:
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Direzione Scientifica IRCCS Galeazzi-Sant'Ambrogio, Milano contact
Italy4 sites, 3 recruiting
- Not yet recruiting
Ospedale San Paolo Bari
Bari, Apulia, 70123
Valeria Internò, MD, +390805843721, valeria.interno@libero.it
Valeria Internò, MD
- Not yet recruiting
Policlinico Bari University Hospital (Bari, Italy)
Bari, Apulia, 70124
Francesco Signorelli, MD, +39805597054, francesco.signorelli@uniba.it
Francesco Signorelli, MD
- Active, not recruiting
Università Vita-Salute San Raffaele
Milan, Lombardy, 20132
- Recruiting
IRCCS Galeazzi-Sant'Ambrogio
Milan, Lombardy, 20157
Direzione Scientifica, +390283502228, direzionescientifica.ogsa@grupposandonato.it
Lorenzo Bello, MD
About this study
The goal of this observational study is to better characterise lower-grade gliomas from a molecular and metabolic point of view, so to identify further subgroups of these tumours with different behaviour and, possibly, different treatment susceptibility.
Participants of prospective metabolic cohort will be subjected to routine treatment, part of the exceeding tutor material will be subjected to advanced molecular-metabolic analyses to desume their metabolic profile to be then correlated with clinical outcome (progression-free survival, overall survival, response to therapy/progression) and diagnosis (astrocytoma/oligodendroglioma and grade).
Critical enzymes identified from metabolic analyses on the first cohort will be tested on a protein level on a retrospective cohort of patients previously operated and for whom fully available clinical history and pathological material is available in Institutional archive (no need for further intervention on these patients) to see if they actually correlate with clinical outcome.
- Conditions
- Lower Grade Glioma
- Keywords
- Lower grade glioma, Metabolomics, Tumor heterogeneity, Patient Stratification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Metabolic Cohort | Patients operated on for lower grade gliomas from whom part of the exceeding pathologic material will be collected for metabolomic profiling | |
| Retrospective FFPE Sample Cohort | Historical patient cohort for whom FFPE sections, full clinical history and pathological data are available. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
time from surgery to evidence of radiological progression at MRI
Measured: (up to 180 months)
Overall Survival (OS)
Time from surgery to tumor-related death
Measured: (up to 180 months)
Secondary outcomes (2)
Histological-molecular diagnosis (integration of immunohistochemistry and molecular evaluation of IDH1/2, ATRX and 1p/19q chromosomal deletion)
Astrocytoma vs Oligodendroglioma (integration of immunohistochemistry and molecular evaluation of IDH1/2, ATRX and 1p/19q chromosomal deletion)
Measured: From date of surgery to date of complete diagnosis (weeks)
Tumor Grade at histology and molecular analysis (CDKN2A/B deletion)
Tumor grade upon histology and molecular analysis (CDKN2A/B deletion)
Measured: From surgery to complete history-molecular diagnosis (weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start14 Nov 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Grade GliomaStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 110 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Collaborators
- Università Vita-Salute San Raffaele, University of Bari, Ospedale San Paolo Bari
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794736
- Sponsor's protocol ID
- STRADIVARI
- Acronym
- STRADIVARI
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 27 Jan 2025
- 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 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STRatifying Adult DIffuse Lower-grade Gliomas Based on Their VARIed Metabolic Profiles (STRADIVARI Project)
- ClinicalTrials.gov ID
- NCT06794736
- Acronym / sponsor ID
- STRADIVARI / STRADIVARI
- Conditions
- Lower Grade Glioma
- Keywords
- Lower grade glioma, Metabolomics, Tumor heterogeneity, Patient Stratification
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Collaborators
- Università Vita-Salute San Raffaele, University of Bari, Ospedale San Paolo Bari
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 27 Jan 2025 (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.
The goal of this observational study is to better characterise lower-grade gliomas from a molecular and metabolic point of view, so to identify further subgroups of these tumours with different behaviour and, possibly, different treatment susceptibility.
Participants of prospective metabolic cohort will be subjected to routine treatment, part of the exceeding tutor material will be subjected to advanced molecular-metabolic analyses to desume their metabolic profile to be then correlated with clinical outcome (progression-free survival, overall survival, response to therapy/progression) and diagnosis (astrocytoma/oligodendroglioma and grade).
Critical enzymes identified from metabolic analyses on the first cohort will be tested on a protein level on a retrospective cohort of patients previously operated and for whom fully available clinical history and pathological material is available in Institutional archive (no need for further intervention on these patients) to see if they actually correlate with clinical outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Metabolic Cohort | – | –Patients operated on for lower grade gliomas from whom part of the exceeding pathologic material will be collected for metabolomic profiling |
| Retrospective FFPE Sample Cohort | – | –Historical patient cohort for whom FFPE sections, full clinical history and pathological data are available. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by brain lower grade gliomas who access Neurosurgery Department (OR, ER, outpatient clinic) at IRCCS Ospedale Galeazzi Sant'Ambrogio and Policlinico Bari, or Oncology Department at Ospedale San Paolo Bari
Key inclusion criteria (4 listed)
- Radiological diagnosis of brain tumor compatible with lower grade glioma
- Full clinical history
- Confirmed diagnosis of lower grade glioma
- Full clinical and radiological history
Key exclusion criteria (3 listed)
- Current pregnancy or lactation
- Patients not able to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression Free Survival (PFS)
Time frame: (up to 180 months)
time from surgery to evidence of radiological progression at MRI
Overall Survival (OS)
Time frame: (up to 180 months)
Time from surgery to tumor-related death
2 secondary outcomes
Histological-molecular diagnosis (integration of immunohistochemistry and molecular evaluation of IDH1/2, ATRX and 1p/19q chromosomal deletion)
Time frame: From date of surgery to date of complete diagnosis (weeks)
Tumor Grade at histology and molecular analysis (CDKN2A/B deletion)
Time frame: From surgery to complete history-molecular diagnosis (weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Lower Grade Glioma
RecruitingObservational study
Metabolomics and Transcriptomics of Low- and High-Grade Gliomas
IDH Wildtype Glioblastoma, IDH Mutant Lower-Grade Gliomas
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ViCToRy: Vorasidenib in Combination With Tumor Specific Peptide Vaccine for Recurrent IDH1 Mutant Lower Grade Gliomas
Low Grade Glioma of Brain
RecruitingPhase 2
Chemotherapy and Radiation Therapy for the Treatment of IDH Wildtype Gliomas or Non-histological (Molecular) Glioblastomas
Anaplastic Astrocytoma, IDH-Wildtype, Anaplastic Oligoastrocytoma
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Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas
Low-grade Glioma
RecruitingPhase 1
Serial MR Imaging and MR Spectroscopic Imaging for the Characterization of Lower Grade Glioma
Recurrent World Health Organization (WHO) Grade II Glioma, Recurrent WHO Grade III Glioma
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.
Direzione Scientifica IRCCS Galeazzi-Sant'Ambrogio, Milano contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Grade Glioma, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 4 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Bello, MD (+390283502228, direzionescientifica.ogsa@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: (up to 180 months)). The study lists 2 primary outcomes in all. 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 27 Jan 2025.