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STRatifying Adult DIffuse Lower-grade Gliomas Based on Their VARIed Metabolic Profiles (STRADIVARI Project)

STRatifying Adult DIffuse Lower-grade Gliomas Based on Their VARIed Metabolic Profiles (STRADIVARI Project)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06794736
Acronym
STRADIVARI
Enrollment
110
Registered
2025-01-27
Start date
2024-11-14
Completion date
2026-08-31
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Grade Glioma

Keywords

Lower grade glioma, Metabolomics, Tumor heterogeneity, Patient Stratification

Brief 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. 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.

Interventions

None listed

Sponsors

Università Vita-Salute San Raffaele
CollaboratorOTHER
University of Bari
CollaboratorOTHER
Ospedale San Paolo Bari
CollaboratorUNKNOWN
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Progression Free Survival (PFS)(up to 180 months)time from surgery to evidence of radiological progression at MRI
Overall Survival (OS)(up to 180 months)Time from surgery to tumor-related death

Secondary

MeasureTime frameDescription
Histological-molecular diagnosis (integration of immunohistochemistry and molecular evaluation of IDH1/2, ATRX and 1p/19q chromosomal deletion)From date of surgery to date of complete diagnosis (weeks)Astrocytoma vs Oligodendroglioma (integration of immunohistochemistry and molecular evaluation of IDH1/2, ATRX and 1p/19q chromosomal deletion)
Tumor Grade at histology and molecular analysis (CDKN2A/B deletion)From surgery to complete history-molecular diagnosis (weeks)Tumor grade upon histology and molecular analysis (CDKN2A/B deletion)

Countries

Italy

Contacts

Primary ContactLorenzo Bello, MD
direzionescientifica.ogsa@grupposandonato.it+390283502228
Backup ContactDirezione Scientifica IRCCS Galeazzi-Sant'Ambrogio, Milano
direzionescientifica.ogsa@grupposandonato.it+390283502228

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026