NCT02307604撤回不适用
Screening Platform of EORTC for Clinical Trials Access in Brain Tumors
European Organisation for Research and Treatment of Cancer - EORTC2 个研究点 分布在 1 个国家开始时间: 2016年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Number of patients with brain malignancy
研究概览
简要总结
The SPECTAbrain protocol describes a structure for screening patients with brain tumors to efficiently allocate eligible patients in relevant therapeutic biomarker-driven clinical trials. Efficiency is promoted through the creation of a clinical database of brain tumor patients and the respective human biological material biobank for molecular characterization. The main objectives are to:
- Allocate patients to clinical trials according to the clinical characteristics and molecular profile of their tumor;
- Identify or validate new molecularly defined subgroups of tumors;
- Investigate the prevalence of novel biomarkers to plan future clinical trials;
- Enable exploratory/future research;
- Facilitate establishment of quality-assured and validated tests for Central Nervous System (CNS) tumor biomarkers;
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
- •Pathologically confirmed newly diagnosed primary CNS tumors, with a focus on diffuse gliomas of grades II, III and IV, meningiomas from patients who are candidates for pharmacotherapy, and rare CNS tumors;
- •Availability of adequate Human Biological Material (HBM): FFPE tissue sample from the primary and/or recurrent tumor and/or metastasis, obtained at the time of surgery or biopsy; minimal amount requested is detailed in the HBM guidelines. Inclusion of samples taken at any recurrence diagnosed during follow-up is strongly encouraged but optional;
- •At least three months life expectancy;
- •Written informed consent according to ICH/GCP and national/local regulations;
- •Absence of exclusion criteria, such as active hepatitis B/C or HIV, second malignancies, severe organ dysfunction, or other comorbidities that will prevent inclusion into clinical trials.
排除标准
- 未提供
结局指标
主要结局
Number of patients with brain malignancy
时间窗: 5 years
次要结局
未报告次要终点
研究者
研究点 (2)
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