Detection of CTCs in Stage III Rectal Cancer Patients Undergoing Neoadjuvant Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The number of Circulating Tumor Cells (CTCs)
研究概览
简要总结
The purpose of this study is to evaluate the value of dynamic change in detecting CTCs in peripheral blood from stage III rectal cancer patients undergoing neoadjuvant Folfox treatment and chemoradiotherapy,before and after surgery.
详细描述
Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time biopsy' of tumor biological activity. Enumeration of CTCs in rectal cancer patients could play an important role in diagnosis, predicting the risk for tumor recurrence and effectiveness of neoadjuvant therapy.
The investigators choose several timepoints to detect the dynamic change of CTCs,1 day before the 1st ,3rd and 5th(if the patient needs before surgery) neoadjuvant therapy course,1 day before and 7days ,3 month,6 month after surgery. Approximately 7.5-mL ethylene diamine tetraacetic acid(EDTA)-blood was drawn by vein puncture from patients with rectal cancer . Briefly, the number of CTCs will be count by the cellsearch system , recorded and analysed by the investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- 是
入选标准
- •Age: >18 years old.
- •Diagnosis of stage III rectal cancer based on histology.
- •Will receive neoadjuvant treatment using Folfox or chemoradiotherapy .
- •Life expectancy: Greater than 3 months.
- •Patients have no severe inflammation, such as vasculitis.
- •Ability to understand the study protocol and a willingness to sign a written informed consent document
排除标准
- •Patients with other primary tumor except rectal cancer.
- •History of coagulation disorders or anemia.
研究组 & 干预措施
Circulating Tumor Cells
Use ISET system to test the number of CTCs from patients before and during treatment.
干预措施: ISET system (Other)
结局指标
主要结局
The number of Circulating Tumor Cells (CTCs)
时间窗: 6 month
次要结局
未报告次要终点