Ireland
--:--IST
Recruiting Observational

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

NCT06794736 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-11-14
Last updated
2025-01-27

Condition(s) studied

Lower Grade Glioma

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • 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

Trial sites (4)

FacilityCityRegionStatus
Ospedale San Paolo Bari Bari Apulia Not Yet Recruiting
Policlinico Bari University Hospital (Bari, Italy) Bari Apulia Not Yet Recruiting
Università Vita-Salute San Raffaele Milan Lombardy Active Not Recruiting
IRCCS Galeazzi-Sant'Ambrogio Milan Lombardy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06794736 on ClinicalTrials.gov ↗ ← All trials in Italy