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临床试验/NCT01022723
NCT01022723Unknown不适用

Clinical Validation of a Microfluidic Device for Isolation and Molecular Characterization of Circulating Tumor Cells

National Cancer Centre, Singapore1 个研究点 分布在 1 个国家目标入组 817 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
817
试验地点
1
主要终点
The validation of the clinical use of a microfluidic device to capture circulating tumor cells (CTC) from a broad range of tumor types

研究概览

简要总结

To evaluate the efficiency of a microdevice for circulating tumor cells isolation and to correlate the circulating titre with response and progression.

详细描述

  • Validate the clinical use of a mircofluidic device to capture circulating timor cells from a broad range of tumor types
  • Characterize and identify these circulating tumor cells and demostrate cell viability with this capture method
  • Apply this technology in clinically relevant settings and correlate to response to treatment and disease progression
  • Elucidate predictive and pharmacodynamic biomarkers in the context of early phase trials of novel therapeutics

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with newly diagnosed metastatic disease planned for palliative chemotherapy
  • Tumor types as specified: non smokers with lung adenocarcinoma, undifferentiated EBV-ISH positive nasopharyneal carcinoma, breast cancer, colorectal cancer, prostate cancer, gastric cancer
  • Informed consent given for the purposes of blood sampling for this study
  • Measurable disease by RECIST criteria of at least 1cm is preferred but not a sine qua non for study accrual

排除标准

  • 未提供

结局指标

主要结局

The validation of the clinical use of a microfluidic device to capture circulating tumor cells (CTC) from a broad range of tumor types

时间窗: 3 years

次要结局

  • Study of predictive and pharmacodynamic biomarkers of the CTC in the context of early phase trials of novel therapeutics(6 years)
  • Characteristics and viability of the CTC with this capture method(3 years)
  • Clinical application of this capture method with the study of CTC titre correlation to treatment outcome(6 years)

研究者

发起方
National Cancer Centre, Singapore
申办方类型
Other
责任方
Sponsor

研究点 (1)

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