NCT01717105Unknown不适用
Observational Post-authorization Prospective Study to Characterize the Incidence of Epidermal Growth Factor Receptor (EGFR) Mutation Positive and Advanced Non-small Cell Lung Cancer Patients and Their Clinical Management in Galicia
Grupo Gallego de Cancer de Pulmon9 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2011年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 225
- 试验地点
- 9
- 主要终点
- Number of patients with epidermal growth factor receptor (EGFR) positive mutation among advanced or metastatic non-small-cell lung cancer (NSCLC) patients in Galicia
研究概览
简要总结
The present study has been designed in order to characterize the incidence of patients with advanced non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) positive mutations and their clinical management in Galicia.
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
- •Inclusion Criteria for patients´ screening:
- •Patients of both sexes aged 18 or more.
- •Histologically confirmed advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) (patients stage III B unsuitable for locoregional treatment, and stage IV).
- •Chemo- naïve patients (Non-Small-Cell Lung Cancer patients who have not received first line systemic cytotoxic chemotherapy).
- •Patients with available tumoral tissue (primary tumor or metastatic area) or cytological samples including fine needle aspirates (primary tumor or metastatic area), bronchial alveolar lavage or bronchial scrapings and pleural effusion.
- •Patients who have granted their written informed consent.
- •Patients must fulfill the inclusion criteria previously mentioned and the following one in order to be enrolled in the study (visit 1) for the follow-up until progression or until 9 months from the beginning of treatment have elapsed:
- •Inclusion Criteria for patients´ follow-up
- •Patients with documented positive mutation in epidermal growth factor receptor (EGFR) (M+).
排除标准
- •Combined histology of non-small cell and small cell lung cancer.
结局指标
主要结局
Number of patients with epidermal growth factor receptor (EGFR) positive mutation among advanced or metastatic non-small-cell lung cancer (NSCLC) patients in Galicia
时间窗: 10 months (recruitment period)
次要结局
- Type of epidermal growth factor receptor (EGFR) mutations: deletion in exon 19, point mutation at codon 858 (L858R) or other (only for EGFR M+ patients)(1 day (Screening Visit))
- Epidermal growth factor receptor (EGFR) mutational status at disease progression in tumor tissue (primary tumor or metastatic samples) and plasma samples (only for EGFR M+ patients)(1 day (Progresion Visit))
- Tumor response (only for epidermal growth factor receptor (EGFR) M+ patients)(From inclusion until disease progression, death or until 9 months from the inclusion of the last patient in the study have elapsed, whichever is earlier.)
- Disease control (only for epidermal growth factor receptor (EGFR) M+ patients)(From inclusion until the end of the study (9 months subsequent to the last patient's inclusion or until lost of follow-up))
- Epidermal growth factor receptor (EGFR) mutational status in tumor tissue (primary tumor or metastatic samples) and plasma samples at screening(1 day (Screening Visit))
- Prescribed first line treatment (only for epidermal growth factor receptor (EGFR) M+ patients)(1 day (First study visit))
- Prescribed second-line treatment after progression (only for epidermal growth factor receptor (EGFR) M+ patients)(1 day (Progression Visit))
- Progression-free survival and overall survival (only for epidermal growth factor receptor (EGFR) M+ patients)(1 day (at the end of the study 9 months subsequent to the last patient's inclusion or until lost of follow-up)
研究者
研究点 (9)
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