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

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status: Enrolling

Conditions: Lower Grade Glioma

Study type: Observational

Funder types: Other

Identifiers

NCT06794736

STRADIVARI

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

110 participants in 2 patient groups

Prospective Metabolic Cohort

Description:

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

Description:

Historical patient cohort for whom FFPE sections, full clinical history and pathological data are available.