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

Recruiting

• Conditions: Lower Grade Glioma

• Registration Number: NCT06794736
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-14
• Status Verified: 2025-01
• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-22
• Last Update Submitted: 2025-01-22
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-27
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (4)

Università Vita-Salute San Raffaele; 🇮🇹 Milano, Lombardy, Italy

IRCCS Galeazzi-Sant'Ambrogio; 🇮🇹 Milano, Lombardy, Italy

Ospedale San Paolo Bari; 🇮🇹 Bari, Puglia, Italy

Policlinico Bari University Hospital (Bari, Italy); 🇮🇹 Bari, Puglia, Italy