NCT02214134已完成不适用
SPECTAlung: Screening Patients With Thoracic Tumors for Efficient Clinical Trial Access
European Organisation for Research and Treatment of Cancer - EORTC17 个研究点 分布在 9 个国家目标入组 539 人开始时间: 2015年5月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 539
- 试验地点
- 17
- 主要终点
- Number of patients with thoracic malignancy (lung cancer, MPM and thymic malignancies) screened and efficiently allocated to biomarker-driven clinical trials.
研究概览
简要总结
SPECTAlung is a program aiming at screening patients with thoracic tumors to identify the molecular characteristics of their disease. The thoracic tumors include lung cancer, malignant pleural mesothelioma, thymoma or thymic carcinoma at any stage. Once the molecular characteristics are identified, there might be the possibility to offer these patients access to targeted clinical trials.
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 lung cancer, MPM, thymoma or thymic carcinoma at any stage;
- •Mandatory availability of adequate Human Biological Material (HBM): FFPE tissue sample from the primary tumor, recurrent tumor, metastasis, obtained at the time of primary 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;
- •Centrally performed confirmation of tumor tissue adequacy in terms of quality/ quantity for central screening;
- •Age ≥ 18 years;
- •At least three months life-expectancy;
- •Written informed consent according to ICH/GCP and national/local regulations.
排除标准
- •Any active malignancy, except pT1-2 prostatic cancer Gleason score < 6, non melanomatous skin cancer or carcinoma in situ of the cervix, in the 5 years before study entry;
- •Active hepatitis B/C or HIV;
- •Any secondary malignancy;
- •Any severe organ dysfunction or other comorbidities that may prevent the inclusion into clinical trials.
结局指标
主要结局
Number of patients with thoracic malignancy (lung cancer, MPM and thymic malignancies) screened and efficiently allocated to biomarker-driven clinical trials.
时间窗: 5 years
次要结局
- Number of exploratory/future research projects developped(5 years)
- Number of patients for whom the description of the biomarkers and correlation to clinical/pathological characteristics can be performed.(5 years)
研究者
研究点 (17)
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