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| Name | Class |
|---|---|
| Università Vita-Salute San Raffaele | OTHER |
| University of Bari | OTHER |
| Ospedale San Paolo Bari | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Metabolic Cohort | Patients operated on for lower grade gliomas from whom part of the exceeding pathologic material will be collected for metabolomic profiling | ||
| Retrospective FFPE Sample Cohort | Historical patient cohort for whom FFPE sections, full clinical history and pathological data are available. |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | time from surgery to evidence of radiological progression at MRI | (up to 180 months) |
| Overall Survival (OS) | Time from surgery to tumor-related death | (up to 180 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From date of surgery to date of complete diagnosis (weeks) |
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Prospective Metabolic Cohort:
Inclusion Criteria:
Exclusion Criteria:
Retrospective Cohort of FFPE samples:
Inclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorenzo Bello, MD | Contact | +390283502228 | direzionescientifica.ogsa@grupposandonato.it | |
| Direzione Scientifica IRCCS Galeazzi-Sant'Ambrogio, Milano | Contact | +390283502228 | direzionescientifica.ogsa@grupposandonato.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Paolo Bari | Not yet recruiting | Bari | Apulia | 70123 | Italy |
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Fresh glioma samples from prospective cohort FFPE section from retrospective cohort
| Tumor Grade at histology and molecular analysis (CDKN2A/B deletion) | Tumor grade upon histology and molecular analysis (CDKN2A/B deletion) | From surgery to complete history-molecular diagnosis (weeks) |
| Policlinico Bari University Hospital (Bari, Italy) | Not yet recruiting | Bari | Apulia | 70124 | Italy |
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| Università Vita-Salute San Raffaele | Active, not recruiting | Milan | Lombardy | 20132 | Italy |
| IRCCS Galeazzi-Sant'Ambrogio | Recruiting | Milan | Lombardy | 20157 | Italy |
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