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NCT Number: NCT06794736

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

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale San Paolo Bari, Bari, Apulia, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Progression Free Survival (PFS)

    Time frame: (up to 180 months)

    time from surgery to evidence of radiological progression at MRI

  2. Overall Survival (OS)

    Time frame: (up to 180 months)

    Time from surgery to tumor-related death

Secondary outcomes

  1. Histological-molecular diagnosis (integration of immunohistochemistry and molecular evaluation of IDH1/2, ATRX and 1p/19q chromosomal deletion)

    Time frame: 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)

  2. Tumor Grade at histology and molecular analysis (CDKN2A/B deletion)

    Time frame: From surgery to complete history-molecular diagnosis (weeks)

    Tumor grade upon histology and molecular analysis (CDKN2A/B deletion)

Study contacts

Contact information is provided by the study sponsor or research team.

Direzione Scientifica IRCCS Galeazzi-Sant'Ambrogio, Milano

CONTACT

[email protected]

+390283502228

Lorenzo Bello, MD

CONTACT

[email protected]

+390283502228

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Ospedale San Paolo Bari
  • University of Bari
  • Università Vita-Salute San Raffaele

Registry information

Acronym: STRADIVARI

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2025
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.