Clinical trial NCT06794736: STRatifying Adult DIffuse Lower-grade Gliomas Based on Their VARIed Metabolic Profiles (STRADIVARI Project)
Official title: STRatifying Adult DIffuse Lower-grade Gliomas Based on Their VARIed Metabolic Profiles (STRADIVARI Project)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lower Grade Glioma
Keywords: Lower grade glioma
Metabolomics
Tumor heterogeneity
Patient Stratification
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
Collaborators: name: Università Vita-Salute San Raffaele
name: University of Bari
name: Ospedale San Paolo Bari
First posted: 2025-01-27
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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

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.


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

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: (up to 180 months)
measure: Overall Survival (OS)
timeFrame: (up to 180 months)
Secondary outcomes:
measure: Histological-molecular diagnosis (integration of immunohistochemistry and molecular evaluation of IDH1/2, ATRX and 1p/19q chromosomal deletion)
timeFrame: From date of surgery to date of complete diagnosis (weeks)
measure: Tumor Grade at histology and molecular analysis (CDKN2A/B deletion)
timeFrame: From surgery to complete history-molecular diagnosis (weeks)
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Università Vita-Salute San Raffaele
state: Lombardy
city: Milano
country: Italy
facility: IRCCS Galeazzi-Sant'Ambrogio
state: Lombardy
city: Bari
country: Italy
facility: Ospedale San Paolo Bari
state: Puglia
city: Bari
country: Italy
facility: Policlinico Bari University Hospital (Bari, Italy)
state: Puglia
Study officials:
References: