NCT02647164Unknown不适用
The Value Of Circulating Tumor Cells In Patient With NSCLC In Postoperative Recurrence Monitoring
GenoSaber0 个研究点目标入组 360 人开始时间: 2016年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 360
- 主要终点
- Circulating tumor cells will be detected by Immunomagnetic negative screening and targeted PCR method.
研究概览
简要总结
The purpose of this study is to assess the value of circulating tumor cells (CTC)for non-small cell lung cancer in the postoperative recurrence monitoring by comparing the CTCs, CT and tumor markers at different time points.The time of CTC and carcinoembryonic antigen(CEA) detection is baseline, 2~7 days, 3 months, 6 months, 12 months, 24 months, 36 months after the surgery. And the time of CT detection is 6 months, 12 months, 24 months, 36 months after the surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age 18-80 years old
- •Patients with histologically documented (stage Ⅰ/Ⅱ/ⅢA ) non-small cell lung cancer.
- •Patients will undergo surgery.
- •Patients with preoperative CTCs ≥8.5 Units / 3 ml
- •Informed consent must be obtained from all patients prior to beginning therapy. Patients should have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients with histologically documented not (stage Ⅰ/Ⅱ/ⅢA ) non-small cell lung cancer.
- •After the operation review, patients' result of CTC, CT and tumor markers is incomplete at the same point.
- •The blood sample isn't collected in predetermined time.
- •The blood samples appear hemolysis.
- •The blood sample isn't enough.
结局指标
主要结局
Circulating tumor cells will be detected by Immunomagnetic negative screening and targeted PCR method.
时间窗: 3 years
次要结局
- Liconography using conventional CT examination results.(3 years)
- carcinoembryonic antigen(CEA) concentration will be detected by electrochemical luminescence.(3 years)
研究者
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