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

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.

Study Overview

• Status: Recruiting
• Conditions: Lower Grade Glioma

• Study Type: Observational
• Enrollment (Estimated): 110

Contacts and Locations

• Study Contact: Name: Lorenzo Bello, MD; Phone Number: +390283502228; Email: direzionescientifica.ogsa@grupposandonato.it
• Study Contact Backup: Name: Direzione Scientifica IRCCS Galeazzi-Sant'Ambrogio, Milano; Phone Number: +390283502228; Email: direzionescientifica.ogsa@grupposandonato.it

Study Locations

• Italy
  • Lombardy
    • Milano, Lombardy, Italy, 20132
      • Active, not recruiting
      • Università Vita-Salute San Raffaele
    • Milano, Lombardy, Italy, 20157
      • Recruiting
      • IRCCS Galeazzi-Sant'Ambrogio
      • Contact: Direzione Scientifica; Phone Number: +390283502228; Email: direzionescientifica.ogsa@grupposandonato.it
      • Contact: Lorenzo Bello, MD
  • Puglia
    • Bari, Puglia, Italy, 70123
      • Not yet recruiting
      • Ospedale San Paolo Bari
      • Contact: Valeria Internò, MD
      • Contact: Valeria Internò, MD; Phone Number: +390805843721; Email: valeria.interno@libero.it
    • Bari, Puglia, Italy, 70124
      • Not yet recruiting
      • Policlinico Bari University Hospital (Bari, Italy)
      • Contact: Francesco Signorelli, MD; Phone Number: +39805597054; Email: francesco.signorelli@uniba.it
      • Contact: Francesco Signorelli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Prospective Metabolic Cohort; 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; Historical patient cohort for whom FFPE sections, full clinical history and pathological data are available.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
• Collaborators: Università Vita-Salute San Raffaele; Policlinico Bari University Hospital (Bari, Italy); Ospedale San Paolo Bari

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Metabolomics; Tumor heterogeneity; Patient Stratification; Lower grade glioma
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: STRADIVARI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No