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临床试验/NCT03171636
NCT03171636已完成不适用

Analysis of the Types and Frequency of EGFR and KRAS Mutations and Clinical-prognostic Correlation in Brazilian Lung Cancer Patients at Erasto Gaertner Hospital, Curitiba, Brazil.

Hospital Erasto Gaertner1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
130
试验地点
1
主要终点
EGRF mutation status

研究概览

简要总结

The assessment of the type and frequency of EGFR and KRAS mutations in lung cancer patients, as well as clinical-prognostic correlation, are crucial in the era of targeted therapies. EGFR-activating mutations predict responsiveness to EGFR tyrosine kinase inhibitors (TKIs) in non-small cell lung cancer (NSCLC) patients and KRAS analysis will be useful in a near future for newest target drugs. In Brazil, few data about the prevalence of EGFR and KRAS mutations is available and their knowledge would allow optimize personalized medicine.

详细描述

Assessment of the types and frequency of EGFR and KRAS mutations in NSCLC, as well clinical-prognostic correlations has been extensively studied in many populations. Few Brazilian studies evaluating mutational status in NSCLC has been done so far, none of then explored the regional background nor have considered the quantitative analysis of mutant cell in each sample. Quantitative analysis of the tumor maybe relevant for treatment design for positive samples, p.e a tumor with 90% of mutant clones versus a 15% of mutant clones, which can be obtained currently by the method of pyrosequencing. In this study, investigators will assess EGFR and KRAS status through the pyrosequencing quantitative technique, and will also correlate these with clinical-pathological variables among both adenocarcinoma and squamous cell histological subtypes. So far, no study that have made this correlation is available.

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

入选标准

  • Brazilian patients with metastatic non-small cell lung cancer.

排除标准

  • Small cell lung cancer and non-metastatic patients.

结局指标

主要结局

EGRF mutation status

时间窗: 3 years

results of presence or absence in all tumor samples (FFPE) obtained from patients

KRAS mutation status

时间窗: 3 years

results of presence or absence in all tumor samples (FFPE) obtained from patients

次要结局

未报告次要终点

研究者

发起方
Hospital Erasto Gaertner
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thais Abreu de Almeira

MD

Hospital Erasto Gaertner

研究点 (1)

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