Blood Biomarker Signature in Glioma

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追踪信息

首次提交日期 ^ICMJE

September 12, 2018

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

July 2009

预计主要完成日期

July 2022 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Biomarkers[ Time Frame: 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).

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Correlation with disease progression[ Time Frame: 5 years ]
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).

描述性信息

简略标题 ^ICMJE

Blood Biomarker Signature in Glioma

正式标题 ^ICMJE

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

简要概况

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

详细说明

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. We 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 we 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, we envisage the translation of our observations into the hospital setting to aid the distinction between glioma grade II and grade III/IV.

研究类型 ^ICMJE

Observational

研究阶段

研究设计 ^ICMJE

分配:
干预模型:
干预模型描述:
盲法: Observational
盲法描述:
主要目的:

适用条件 ^ICMJE

干预项目 ^ICMJE

Other: Non-interventional
Translational, observational study

研究工具

: Cohort 1
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)
: Cohort 2
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

招募信息

招募状态 ^ICMJE

Recruiting

预计入组 ^ICMJE

130

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

July 2027

预计主要完成日期

July 2022 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: 1. All patients with suspected newly diagnosed glioma (grade 2 or 3 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

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

Ireland

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

Cancer Trials Ireland

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Cancer Ireland, Glasnevin Dublin 11, Ireland Cancer Trials Ireland

PRS 账户

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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