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 volunteersQualifiers
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
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Progression Free Survival (PFS)
time from surgery to evidence of radiological progression at MRI
Overall Survival (OS)
Time from surgery to tumor-related death
Secondary outcomes
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)
Tumor Grade at histology and molecular analysis (CDKN2A/B deletion)
Tumor grade upon histology and molecular analysis (CDKN2A/B deletion)
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