Establishment of a Brain and Spinal Tumor Tissue Bank and Clinical Data Repository for Identifying Molecular Markers of Clinical Outcome
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Collect, annotate, and store fresh frozen specimens of normal tissue, tumors, and pre-malignant lesions for biological investigation.
研究概览
简要总结
The purpose of this study is to establish a Brain and Spinal Tumor Tissue/Specimen repository to serve as a resource for current and future scientific studies.
详细描述
Glioblastoma multiforme (GBM) is the most common and lethal primary Brain and Spinal Tumor in adults. It is nearly uniformly fatal, with a median survival of approximately one year, despite modern treatment modalities. Efforts to understand why some patients live longer or shorter than the average may provide insights into the biology of these neoplasms. For years, researchers have tried to identify independent predictors that could help in treatment planning. With the recent interest in molecular biology and molecular genetics, tumor markers are now being examined as potential predictors. A marker that could predict tumor response to therapy, the likelihood of recurrence, and survival would thus be quite useful.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a suspected or confirmed diagnosis of Brain and Spinal Tumor
- •Age greater than 20
- •Signed consent
排除标准
- •Known HIV infection
- •Any other clinical condition which, in the opinion of the principal investigator, would not allow completion of this study
结局指标
主要结局
Collect, annotate, and store fresh frozen specimens of normal tissue, tumors, and pre-malignant lesions for biological investigation.
时间窗: 5 years
次要结局
- Collect, process, and store serum, plasma and isolate lymphocytes from blood drawn from patients with Brain and Spinal Tumor(5 years)
- To correlate tumor genotype and signaling abnormalities with clinical response to NAT2, EGFR, MGMT and/or other potential molecular targets inhibitors(5 years)
- Analysis of laboratory findings in relationship to patient demographics and clinical course(5 years)
- To utilize the clinical database to perform clinical and pathological correlation with the results of current and future scientific studies(5 years)
- Establish a database to link materials acquisition, pathologic, and clinical information on patients who participate in the protocol(5 years)
- To evaluate various NAT2, EGFR and MGMT for evidence of genomic and biochemical activation(5 years)
- To test the effect of small molecule inhibitors on the activation of wild-type and mutant NAT2, EGFR, MGMT and/or other potential molecular targets(5 years)