exRNA Biomarkers for Human Glioma

人类神经胶质瘤的 exRNA 生物标志物

• 批准号: 8711592
• 负责人: Bob S Carter
• 金额: $ 49.49万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-01 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8711592
• 关键词: Algorithms; Biological Assay; Biological Markers; Biopsy; Blood; Blood Tests; Brain; Brain Neoplasms; Brain Part; Cerebrospinal Fluid; Clinical; Clinical Research; Clinical Trials; Collection; Data; Detection; Diagnosis; Diagnostic; Diagnostic Procedure; Disease; Glioma; Goals; Human; Institution; Language; Methods; MicroRNAs; Movement; Mutation; Patients; Performance; Phase; Procedures; Prognostic Marker; Protocols documentation; Quality of life; RNA; RNA Sequences; RNA analysis; Research; Research Personnel; Risk; Sampling; Sensitivity and Specificity; Series; Source; Technology; Testing; Tumor Tissue; Work; brain surgery; clinical practice; digital; economic impact; epidermal growth factor receptor VIII; exome sequencing; extracellular; improved; novel; patient population; prospective; public health relevance; tumor; validation studies

DESCRIPTION (provided by applicant): The non-invasive diagnosis of human glioma could improve the quality of life of patients with this disease by allowing patients to be directly diagnosed or stratified for treatment without the need of an invasive brain biopsy. In this study, the investigators propose to develop novel extracellular RNA biomarkers for the diagnosis of human glioma tumors. Using a prioritized panel of tumor specific extracellular RNA (exRNA) genetic changes, we will test different competing technologies (qPCR, digital PCR, exome sequencing, and DMR) for detecting exRNA candidate biomarkers in blood and CSF of glioma patients. In the UH3 phase of study, we will create a consortium of institutions to provide rapid prospective collection of tumor tissue CSF, and blood from glioma patients and establish common protocols for CSF and blood collection to support clinical diagnostic glioma exRNA assays. We will then validate the diagnosis of glioma by exRNA using blood or CSF exRNA assays (as prioritized from the UH2 phase) and tested in two clinical patient population; 1) suspected low grade and 2) suspected high grade glioma. Prototypical markers that will be tested will include the detection of IDH1 mutations in low grade tumors and EGFRvIII in high grade tumors. We anticipate the ability to determine the sensitivity and specificity with which a CSF or blood test can be used to diagnosis human glioma. We further anticipate that in patients with difficult to biopsy tumors, the results o this study will yield a method for diagnosing brain tumors non-invasively thus reducing the need for invasive brain surgery and appropriately stratifying patients for targeted therapies.

描述（由申请人提供）： 人神经胶质瘤的非侵入性诊断可以通过允许患者直接诊断或分层进行治疗而无需进行侵入性脑活检，从而改善该疾病患者的生活质量。在这项研究中，研究人员建议开发新的细胞外RNA生物标志物来诊断人神经胶质瘤肿瘤。使用优先的肿瘤特异性细胞外RNA（EXRNA）遗传变化，我们将测试不同的竞争技术（QPCR，数字PCR，外显子组测序和DMR），以检测胶质瘤患者血液和CSF中EXRNA候选生物标志物。 在UH3研究阶段，我们将创建一个机构的财团，以提供肿瘤组织CSF的快速前瞻性收集，以及来自神经胶质瘤患者的血液，并为CSF和血液收集建立共同的方案，以支持临床诊断神经胶质瘤EXRNA分析。然后，我们将使用血液或CSF EXRNA分析（从UH2期优先考虑）通过EXRNA验证神经胶质瘤的诊断，并在两个临床患者人群中进行测试； 1）怀疑的低级和2）可疑的高级神经胶质瘤。将要测试的原型标记将包括在高级肿瘤中检测IDH1突变和高级肿瘤中的EGFRVIII。我们预计可以确定CSF或血液检查可用于诊断人神经胶质瘤的敏感性和特异性的能力。我们进一步预期，在难以活检肿瘤的患者中，该研究的结果将产生一种诊断脑肿瘤非侵入性的方法，从而减少了对侵入性脑手术的需求，并适当地对靶向疗法进行了适当分层。