NCT03058809Unknown1 期
Evaluation of the Saftey and Efficacy of the Viatar™ Oncopheresis System in Removing Circulating Tumor Cells From Whole Blood
Viatar LLC0 个研究点目标入组 100 人开始时间: 2018年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 100
- 主要终点
- Change in Circulating Tumor Cells
研究概览
简要总结
This study will access the safety and efficacy of the Viatar™ Oncopheresis System to remove a meaningful quantity of circulating tumor cells from the blood of subjects' with breast, colon or prostate solid tumor cancers in a single treatment. CTC reduction will be measured as the change in circulating tumor cells as determined before and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of breast, colon or prostate cancer
- •No prior cancer therapy or failed first line therapy
- •>= 25 CTC per 7.5 mL of blood within 1 week prior to oncopheresis treatment
- •> 1 month life expectancy
- •Adequate baseline hematological function as assessed by the following laboratory values:
- •Hemoglobin > 9 g/dl
- •Platelets > 100,000/mm3
- •WBC > 3,000/mm3
- •Absolute Neutrophil Count > 1,500/mm3
排除标准
- •Coagulation disorders and/or a history of thromboembolic complications, including known hypersensitivity to citrate: e.g., abnormal platelet count, prothrombin time and partial activated thromboplastin time and with a history of deep vein thrombus or pulmonary embolism
- •Patients with known immunodeficiency virus (HIV)
结局指标
主要结局
Change in Circulating Tumor Cells
时间窗: % change will be determined on the day of treatment
% change in enumerated circulating tumor cells after treatment with Viatar Oncopheresis System
次要结局
- Immune system activation(Immune system activation biomarkers will be followed for 7 days post treatment)
研究者
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