Characterizing lower-grade gliomas based on metabolic profiles
STRatifying Adult DIffuse Lower-grade Gliomas Based on Their VARIed Metabolic Profiles (STRADIVARI Project)
This study looks at the metabolic profiles of lower-grade gliomas to see how they affect treatment responses and survival in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Academic / other |
| Locations | 4 sites (Bari, Apulia and 3 other locations) |
| Trial ID | NCT06794736 on ClinicalTrials.gov |
What this trial studies
This observational study aims to better understand lower-grade gliomas by analyzing their molecular and metabolic characteristics. Participants will undergo routine treatment while their tumor samples are subjected to advanced metabolic analyses to identify distinct subgroups with varying behaviors and treatment responses. The study will correlate metabolic profiles with clinical outcomes such as progression-free survival and overall survival. Additionally, critical enzymes identified will be tested in a retrospective cohort to validate findings without requiring further patient intervention.
Who should consider this trial
Good fit: Ideal candidates include individuals with a radiological diagnosis of lower-grade glioma and a complete clinical history.
Not a fit: Patients who are currently pregnant, lactating, or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for patients with lower-grade gliomas.
How similar studies have performed: Other studies have shown promise in using metabolic profiling for tumor characterization, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Prospective Metabolic Cohort: Inclusion Criteria: * Radiological diagnosis of brain tumor compatible with lower grade glioma * Full clinical history Exclusion Criteria: * Current pregnancy or lactation * Patients not able to provide informed consent Retrospective Cohort of FFPE samples: Inclusion Criteria: * Confirmed diagnosis of lower grade glioma * Full clinical and radiological history
Where this trial is running
Bari, Apulia and 3 other locations
- Ospedale San Paolo Bari — Bari, Apulia, Italy (Not_yet_recruiting)
- Policlinico Bari University Hospital (Bari, Italy) — Bari, Apulia, Italy (Not_yet_recruiting)
- Università Vita-Salute San Raffaele — Milan, Lombardy, Italy (Active_not_recruiting)
- IRCCS Galeazzi-Sant'Ambrogio — Milan, Lombardy, Italy (Recruiting)
Study contacts
- Study coordinator: Lorenzo Bello, MD
- Email: direzionescientifica.ogsa@grupposandonato.it
- Phone: +390283502228
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.