Prostate Cancer Circulating Tumor Cells Based on Epithelial-Mesenchymal Transition Biology
2015年7月28日 更新者：Duke University
Development of a Novel Method to Detect Prostate Cancer Circulating Tumor Cells (CTCs) Based on Epithelial-mesenchymal Transition Biology
This is a minimal risk correlative clinical blood-drawing protocol.
The objective of this lead in pilot component is to determine whether Circulating Tumor Cells (CTC's) can be captured using the novel mesenchymal-marker based Near Infrared-Emissive Polymersomes (NIR-EPs), the PSMA-based NIR-EP, and the epithelial EpCAM-based NIR-EP.
If successful, the capture method will be evaluated further in the larger comparative study.
研究概览
研究类型
介入性
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
描述
Inclusion Criteria:
- histologically confirmed diagnosis of adenocarcinoma of the prostate
- Clinical or radiographic evidence of metastatic disease
Evidence of disease progression on androgen deprivation therapy (ADT) as evidenced by either of the following in the past:
- Two consecutive PSA levels greater than the PSA nadir achieved on ADT, separated by greater than one week
- Radiographic evidence of disease progression as defined by new bone scan lesions or soft tissue/visceral metastases >2 cm in diameter.
- Clinical progression as determined by the treating physician.
- Age greater than 18 years.
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- History of intercurrent or past medical or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Metastatic prostate cancer
Near infrared (NIR) emissive nanotechnology
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Non-detection rate of CTC's in men with CRPC
大体时间：at baseline, month 3, and progression (up to 18 months)
|
Non-detection rate of CTC's in men with CRPC will be measured at baseline, month 3, and at progression
|
at baseline, month 3, and progression (up to 18 months)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Median number of CTC's detected by each capture method
大体时间：baseline, month 3, and progression (up to 18 months)
|
Calculate for each patient the number of CTC's detected by each capture method (novel and standard).
|
baseline, month 3, and progression (up to 18 months)
|
|
Change in median number of CTC's for each method
大体时间：at baseline, month 3, and progression (up to 18 months)
|
For each method, we will plot the change across time (baseline, cycle 3, and at progression) in the median number of CTC's for each method (novel and standard).
|
at baseline, month 3, and progression (up to 18 months)
|
|
Correlation of CTC enumeration with presenting clinical stage
大体时间：at baseline, month 3, and progression (up to 18 months)
|
at baseline, month 3, and progression (up to 18 months)
|
|
|
Correlation of CTC enumeration with sites of metastatic disease
大体时间：at baseline, month 3, and progression (up to 18 months)
|
at baseline, month 3, and progression (up to 18 months)
|
|
|
Correlation of CTC enumeration with Gleason sum
大体时间：at baseline, month 3, and progression (up to 18 months)
|
at baseline, month 3, and progression (up to 18 months)
|
|
|
Correlation of CTC enumeration with PSA kinetics
大体时间：at baseline, month 3, and progression (up to 18 months)
|
at baseline, month 3, and progression (up to 18 months)
|
|
|
Correlation of CTC enumeration with therapies
大体时间：at baseline, month 3, and progression (up to 18 months)
|
at baseline, month 3, and progression (up to 18 months)
|
|
|
Correlation of CTC enumeration with overall survival
大体时间：at baseline, month 3, and progression (up to 18 months)
|
at baseline, month 3, and progression (up to 18 months)
|
|
|
Correlation of CTC enumeration with progression-free survival
大体时间：at baseline, month 3, and progression (up to 18 months)
|
at baseline, month 3, and progression (up to 18 months)
|
|
|
Correlation of CTC enumeration with response to therapy
大体时间：at baseline, month 3, and progression (up to 18 months)
|
at baseline, month 3, and progression (up to 18 months)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Andrew Armstrong, MD、Duke University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年5月1日
初级完成 (实际的)
2015年6月1日
研究完成 (实际的)
2015年6月1日
研究注册日期
首次提交
2013年12月18日
首先提交符合 QC 标准的
2013年12月23日
首次发布 (估计)
2013年12月30日
研究记录更新
最后更新发布 (估计)
2015年7月30日
上次提交的符合 QC 标准的更新
2015年7月28日
最后验证
2015年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.