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临床试验/NCT01163058
NCT01163058Unknown不适用

Retrospective Analysis Evaluating Molecular Factors of Primary Resistance to Tyrosine Kinase Inhibitors in Metastatic Non Small Cell Lung Cancer Patients

Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Determine the incidence of EGFR (Epidermal growth factor ) and KRAS (Kirsten ras sarcoma viral oncogene homolog ) mutations in 300 NSCLC (non small cell lung cancer) patients treated with gefitinib or erlotinib

研究概览

简要总结

Aim of the present retrospective study is to evaluate molecular factors of primary resistance to tyrosine kinase inhibitors in metastatic non small cell lung cancer (NSCLC) patients. The investigators assess first, the incidence of epidermal growth factor receptor (EGFR) and Kirsten ras sarcoma viral oncogene homolog (KRAS) mutations, SOS and hepatocyte growth factor (HGF) expression, anaplastic lymphoma kinase (ALK) translocation and expression and, secondly, the investigators correlate molecular markers with clinical features and outcome in terms of response rate, progression free survival and overall survival.

详细描述

Non small cell lung cancer patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histologically confirmed diagnosis of NSCLC (non small cell lung cancer) with available tumor tissue for mutational analysis
  • Metastatic disease treated with gefitinib or erlotinib
  • Presence of at least one measurable lesion according to RECIST criteria

排除标准

  • No tumor tissue available
  • No clinical data available

结局指标

主要结局

Determine the incidence of EGFR (Epidermal growth factor ) and KRAS (Kirsten ras sarcoma viral oncogene homolog ) mutations in 300 NSCLC (non small cell lung cancer) patients treated with gefitinib or erlotinib

时间窗: 1 year

次要结局

  • Investigate the association of clinical features such as sex, age, smoking history and histology with oncogenic alterations.(1 year)

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other

研究点 (1)

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