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| Name | Class |
|---|---|
| FSBI "Federal Neurosurgical Center" Novosibirsk, Russia | UNKNOWN |
| Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan | OTHER_GOV |
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This is an exploratory, non-interventional and translational clinical study. The aim of this study is to analyze blood and cerebrospinal fluid metabolomic profile in glioma patients.
The analysis of metabolic profile in the plasma and CSF could become the new less invasive approach in the establishing diagnosis as well as an important prognostic factor in patients with glioma. The researches will assess the blood and CSF metabolic profile in patients with different types of gliomas as well as in patient without ones. This can help to find new biomarkers for low- and high-grade gliomas correlating with patient outcomes.
Blood and CSF samples will be collected from patients with suspected newly diagnosed low-grade (I-II) or high-grade (III-IV) gliomas as well as from patients who have hospitalized for reconstructive surgery after craniofacial trauma. All samples will be collected before any surgical intervention and at various follow-up time points until progression or death. The results of the study are planned to be translated into the hospital setting as support to other diagnostics procedures and to the differential diagnosis between glioma grades.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 / High grade Glioma | Cohort 1:
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| Cohort 2 / Low grade Glioma | Cohort 2:
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| Cohort 3 / Conditionally healthy volunteers | Cohort 3:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non- interventional | Other | Translational, observational study |
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| Measure | Description | Time Frame |
|---|---|---|
| Metabolic phenotype of glioma patients | Plasma and CSF aminoacids, acylcarnitines, and other metabolites in glioma patients compared to conditionally healthy volunteers by high-performance liquid chromatography coupled with tandem mass spectrometry. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Time between date of diagnosis and date of death | 5 years |
| Progression free survival (PFS) | Time between date of diagnosis and date of disease progression |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with suspected newly diagnosed glioma with planned surgical intervention will be eligible.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novosibirsk State University | Novosibirsk | Novosibirsk Oblast | 630090 | Russia |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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Plasma, cerebrospinal fluid (CSF)
| 5 years |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001254 | Astrocytoma |