Blood and Cerebrospinal Fluid Metabolomic Profile in Glioma Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Unique Blood and CSF Metabolic Profile Association With Gliomas in Adults

Conditions
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Glioma, Glioblastoma Multiforme

Intervention / Treatment
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* Other: Non- interventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with suspected newly diagnosed glioma (grade I, II, III or glioblastoma) with planned surgical intervention (resection or biopsy). Patient aged 18 years or older Patients have to be able to give informed consent Exclusion Criteria: Prior Radiotherapy to the central nervous system Prior Chemotherapy within the last 5 years Any prior central nervous system malignancy Any surgery during last 6 month

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1 / High grade Glioma<br>Cohort 1: Histologically confirmed high-grade glioma (grade III and grade IV (glioblastoma (GBM))) Planned treatment (surgery followed by radiation therapy (RT) alone or Chemotherapy alone or a combination of RT/Chemotherapy) | Other: Non- interventional<br>* Translational, observational study<br>|
| Cohort 2 / Low grade Glioma<br>Cohort 2: Histologically confirmed low-grade (grade I/II) glioma Planned treatment either expectant monitoring or surgery followed by RT alone or Chemotherapy alone or a combination of RT/Chemotherapy | Other: Non- interventional<br>* Translational, observational study<br>|
| Cohort 3 / Conditionally healthy volunteers<br>Cohort 3: No oncological disease was diagnosed Planned treatment (reconstructive surgery after craniofacial trauma) | Other: Non- interventional<br>* Translational, observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolomic profile, Biomarkers