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As per the HRBs new funding model, HRBs investment will not support costs associated with routine patient care or translational studies, biobanks, patient registries and questionnaires. Therefore, a decision was made to cease further study follow up.
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| Name | Class |
|---|---|
| Royal College of Surgeons, Ireland | OTHER |
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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.
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
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.
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional | Other | Translational, observational study |
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| 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
| 5 years |
| 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 |
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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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| Name | Affiliation | Role |
|---|---|---|
| Jochen Prehn | Cancer Trials Ireland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont Hospital | Dublin | Dublin 9 | Ireland |
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