Are Gliomas in Adults Associated With a Unique Identifying Blood Biomarker Signature?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Identification of protein and miRNA biomarker ignatures
研究概览
简要总结
This is an exploratory, translational and non-interventional clinical study. The aim of this study is to identify a blood biomarker signature for glioma.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Prior Radiotherapy to the central nervous system
- •Prior Chemotherapy within the last 5 years
- •Any prior central nervous system malignancy
结局指标
主要结局
Identification of protein and miRNA biomarker ignatures
时间窗: 5 years
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).
次要结局
- Correlation with disease progression(5 years)