STRatifying Adult DIffuse Lower-grade Gliomas Based on Their VARIed Metabolic Profiles (STRADIVARI Project)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lower Grade Glioma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Progression Free Survival (PFS) [Time frame: (up to 180 months)]
- Overall Survival (OS) [Time frame: (up to 180 months)]
Secondary outcome measures (2)
- 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)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 4 centers
- Ospedale San Paolo Bari — Bari
- Policlinico Bari University Hospital (Bari, Italy) — Bari
- Università Vita-Salute San Raffaele — Milan
- IRCCS Galeazzi-Sant'Ambrogio — Milan
Identifiers
NCT: NCT06794736 · STRADIVARI