Blood Biomarker Signature in Glioma

Study Overview
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Brief Summary
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This is an exploratory, translational and non-interventional clinical study. The aim of this study is to identify a blood biomarker signature for glioma.

Detailed Description
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The identification of biomarkers (proteins, peptides and micro RNAs (miRNAs)) in the serum of patients with glioma would be a new, less invasive approach, which could help in the diagnosis of a glioma, and potentially help guide therapeutic decisions. The investigators will investigate the existence of biomarker profiles, which can distinguish between low and high grade gliomas correlate with patient outcomes including response to treatment and survival indicate progression from a low to a high grade glioma. In this study the investigators collect and analyse blood samples taken from patients with suspected newly diagnosed grade II/III glioma or glioblastoma multiforme (GBM). Blood samples will be collected before any surgical intervention (resection or biopsy) and at various follow-up time points until progression or death. Based on the known natural history of gliomas (described above), it is planned to follow patients with grade III/IV tumours, who receive treatment, for up to 3 years and those with grade II-III tumours, (irrespective of treatment) for up to 5 years. Ultimately, the investigators envisage the translation of our observations into the hospital setting to aid the distinction between glioma grade II and grade III/IV.

Official Title
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Are Gliomas in Adults Associated With a Unique Identifying Blood Biomarker Signature?

Conditions
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Glioma of Brain

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 2 or 3 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

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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No

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) or glioblastoma (GBM, astrocytoma grade IV) Planned treatment (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 II) glioma Planned treatment either expectant monitoring or RT alone or Chemotherapy alone or a combination of RT/Chemotherapy | 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 |
| --- | --- | --- |
| Identification of protein and miRNA biomarker ignatures | Identification of protein and miRNA biomarker signatures in serum of glioma patients as assessed by surface-enhanced laser desorption ionization - time of flight (SELDI-TOF), Isobaric tags for relative and absolute quantitation (iTRAQ) and miRNA array technologies. Profiling experiments will be performed on the serum samples to find unique glioma associated serum biomarkers to determine if the levels of discovered biomarkers accurately reflect glioma grade. to investigate if alterations in levels of glioma associated markers predict glioma progression from low grade to high grade Profiling patient's protein and miRNA biomarker signatures will allow association of expression patterns with tumour grade. We will determine if alterations in levels of identified serum biomarkers correlate with disease progression and patient outcome, including tumour response, time to progression (TTP) and overall survival (OS). | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation with disease progression | The secondary objectives are to determine if alterations in levels of identified serum biomarkers correlate with disease progression and patient outcome, including tumour response, time to progression (TTP) and overall survival (OS). | 5 years |