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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorI.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Radiological diagnosis of brain tumor compatible with lower grade glioma

Full clinical history

Disqualifiers

Current pregnancy or lactation

Patients not able to provide informed consent

Confirmed diagnosis of lower grade glioma

Full clinical and radiological history

Trial 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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

110 Participants
are grouped into 2 trial groups
Group A: Prospective Metabolic Cohort
Group B: Retrospective FFPE Sample Cohort

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

time from surgery to evidence of radiological progression at MRI

Time frame
(up to 180 months)
2

Overall Survival (OS)

Time from surgery to tumor-related death

Time frame
(up to 180 months)

Secondary outcomes

1

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)

Time frame
From date of surgery to date of complete diagnosis (weeks)
2

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

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Università Vita-Salute San Raffaele

Collaborator

University of Bari

Collaborator

Ospedale San Paolo Bari

Collaborator