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临床试验/NCT01052818
NCT01052818Unknown不适用

Therapeutic and Prognostic Impact of Circulating Tumor Cells in Peripheral Blood in Patients With Non Small-cell Lung Cancer

National Institute of Cancerología1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2007年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Response rate, progression-free survival and over-all survival

研究概览

简要总结

The purpose of the study is to evaluate the association between the number of circulating tumor cells and response to treatment in non small-cell lung cancer patients

详细描述

In spite of technological advantages in diagnosis and treatment, lung cancer remains one of the most deadly malignant neoplasias. Moreover, there are no markers for monitoring response to treatment. The objective of the study is to associate the number of circulating tumor cells (CTC) before and after treatment and correlate it with tumor response rate, progression-free survival and overall survival.

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

  • Histopathologic diagnosis of non small-cell lung cancer
  • Clinical stage IV
  • ECOG functional status 0 or 1
  • No renal function alteration (GFR >50%)
  • No hepatic function alteration (ALT and AST less than 2 times its normal value)
  • Leucocytes more than 2,000/mcl
  • Hemoglobin more than 10mg/dL
  • Platelets more than 100,000/mcl

排除标准

  • Non-advanced disease

结局指标

主要结局

Response rate, progression-free survival and over-all survival

时间窗: 4 years

次要结局

  • Quantification of CTCs(4 years)

研究者

发起方
National Institute of Cancerología
申办方类型
Other Gov

研究点 (1)

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