Glioblastoma Multiforme, Glioma
Conditions
Keywords
Metabolomic profile, Biomarkers
Brief summary
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.
Detailed description
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.
Interventions
OTHERNon- interventional
Translational, observational study
Sponsors
FSBI Federal Neurosurgical Center Novosibirsk, Russia
Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan
Novosibirsk State University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. All patients with suspected newly diagnosed glioma (grade I, II, III or glioblastoma) with planned surgical intervention (resection or biopsy). 2. Patient aged 18 years or older 3. Patients have to be able to give informed consent
Exclusion criteria
1. Prior Radiotherapy to the central nervous system 2. Prior Chemotherapy within the last 5 years 3. Any prior central nervous system malignancy 4. Any surgery during last 6 month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic phenotype of glioma patients | 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 5 years | Time between date of diagnosis and date of death |
| Progression free survival (PFS) | 5 years | Time between date of diagnosis and date of disease progression |
Countries
Russia
Outcome results
None listed