An observational study in Lower Grade Glioma, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Recruiting at 4 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-27.
Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Observational
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.
1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.
This study's planned enrollment of 110 is above the median of 88 across 238 observational studies indexed under Glioma.
Browse Glioma studies →I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the lead sponsor of 157 studies on the registry; 58 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Prospective Metabolic Cohort:
Inclusion Criteria:
Exclusion Criteria:
Retrospective Cohort of FFPE samples:
Inclusion Criteria:
Patients operated on for lower grade gliomas from whom part of the exceeding pathologic material will be collected for metabolomic profiling
Historical patient cohort for whom FFPE sections, full clinical history and pathological data are available.
Progression Free Survival (PFS)
time from surgery to evidence of radiological progression at MRI
Time frame: (up to 180 months)
Overall Survival (OS)
Time from surgery to tumor-related death
Time frame: (up to 180 months)
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)
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)
Plan to share: Undecided
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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio