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临床试验/NCT02288754
NCT02288754Unknown不适用

Detection of Tumor DNA in Blood Samples From Patients With Late Stage Cancer and "Healthy Controls"

Lexent Bio, Inc.1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
1
主要终点
Correlation between the tumor load score and patient response to therapies.

研究概览

简要总结

The aim of this study is to employ genomic detection methodologies to measure the relative amount of tumor nucleic acids in the blood of a cancer patient with diagnosed metastatic disease that is either commencing, currently undergoing or completed cytotoxic chemotherapy treatment. More generally, this approach will allow us to develop a quantitative measure of therapy efficacy via the counting of the relative changes in tumor molecules over the course of treatment.

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

  • Age 18 years or older
  • Have metastatic disease with from a solid tumor (e.g. breast, lung, colon, pancreas, ovary, prostate...) or stage II or III solid tumors undergoing curative surgery or neoadjuvant therapy followed by surgery
  • Starting treatment or a new line of treatment
  • Able to understand and grant informed consent
  • Able to have their blood drawn

排除标准

  • Unable to grant informed consent or comply with all study procedures.
  • Has a hematological malignancy, i.e. myeloma, lymphoma, MDS, leukemia

结局指标

主要结局

Correlation between the tumor load score and patient response to therapies.

时间窗: 5 years

Determination of a direct correlation between the tumor load score and patient response to therapies.

次要结局

  • Determination of particular mutation events which underlie the basis of any established correlation with therapy response.(5 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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