The Detection of Circulating Tumor Cells (CTCs) in Breast Cancer With a Novel in Vivo Device
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Validation of CellCollector
研究概览
简要总结
The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide which is CE approved. Application data of CellCollector in China is not available now. The purpose of this clinical trial is to confirm the validation and safety of CellCollector in Chinese patients.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Metastasis breast cancer confirmed with imaging examination
- •Have agreed to undergo CTC analysis in vivo;
排除标准
- •Non-metastasis breast cancer
研究组 & 干预措施
Control Group
benign breast tumour Age：18-75 ECOG:0-2
干预措施: Circulating tumor cells (Device)
MBC Group
metastatic breast cancer Age：18-75 ECOG:0-2
干预措施: Circulating tumor cells (Device)
结局指标
主要结局
Validation of CellCollector
时间窗: 6 month
CTC enumeration and detection rate in Chinese patients with metastasis breast cancer will be analyzed by using CellCollector.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: 6 month
Number of participants with treatment-related adverse events and blood IgE level will be analyzed after CellCollector application.
次要结局
未报告次要终点