NCT02025413已完成不适用
Isolation of Circulating Tumor Cells Using a Novel EMT-Based Capture Method
Duke University2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2011年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Feasibility as measured by successfully detecting at least one CTC in at least 2 out of 10 subjects, comparing the non-detection rate over time.
研究概览
简要总结
The primary objective of the preliminary lead-in study is to determine whether circulating tumor cells in patients with metastatic progressive castration-resistant prostate cancer or metastatic progressive breast cancer can be captured using a novel mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based).
The primary objective of each comparative cohort (second stage, prostate cancer) is to compare the non-detection rate of circulating tumor cells between the standard and novel methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer patients will be eligible for inclusion in this study only if all of the following criteria apply:
- •Histologically confirmed diagnosis of adenocarcinoma of the prostate. Small cell or neuroendocrine tumors of the prostate are also permitted.
- •Clinical or radiographic evidence of metastatic disease.
- •Castrate levels of testosterone (<50 ng/dl)
- •Evidence of disease progression on or following most recent therapy as evidenced clinically by the treating physician or by either of the following:
- •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 growth of soft tissue/visceral metastases >1 cm in diameter (2 cm for lymph nodes).
- •Age > 18 years.
- •Ability to understand and the willingness to sign a written informed consent document.
- •Breast cancer patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply:
- •Histologically confirmed diagnosis of invasive breast cancer.
- •Clinical or radiographic evidence of metastatic disease.
- •Evidence of disease progression on the current or following the most recent therapy, determined either clinically by the treating physician or by radiographic evidence as defined by new bone scan lesions or soft tissue/visceral metastases >1 cm in diameter (2 cm for lymph nodes).
- •Age > 18 years.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •A patient will not be eligible for inclusion in this study if any of the following criteria apply:
- •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).
- •Treatment with an anthracycline or mitoxantrone within 1 week of CTC collection
研究组 & 干预措施
Metastatic progressive castration-resistant prostate cancer
Other
Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)
干预措施: Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based) (Device)
Metastatic progressive breast cancer
Other
Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)
干预措施: Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based) (Device)
结局指标
主要结局
Feasibility as measured by successfully detecting at least one CTC in at least 2 out of 10 subjects, comparing the non-detection rate over time.
时间窗: The change in non-detection rate will be measured by comparing samples from Screening, Cycle 3, and Progression (up to 3 years)
次要结局
- Changes in CTCs (using each method) over time during systemic therapy(Screening, Cycle 3, Progression (up to 3 years))
- Median number of CTCs detected by each method over time(Changes will be measured from screening, cycle 3 and progression (up to 3 years))
- Change in correlation of CTC enumeration using each method with baseline clinical and pathologic disease characteristics (for example, clinical stage, site of metastatic disease, Gleason sum for CRPC, PSA for CRPC, previous therapies)(Screening, Cycle 3, Progression (up to 3 years))
- Comparison of the proportion of patients with no detectable CTCs between capture methods over time(Change will be measured by comparing samples at Screening, Cycle 3, Progression (up to 3 years))
研究者
研究点 (2)
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