Application of Detecting Circulating Tumor Cells in the Accurate Diagnosis and Treatment of Early Stage Lung Adenocarcinoma
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
In 2015-2016, 224,390 cases were newly diagnosed with lung cancer in USA. Of all the cases, 83% are non-small cell lung cancer (NSCLC). Currently, the 5-year survival rate of NSCLC patients is 21%, and more than 25% of early stage NSCLC patients, who have undergone surgical treatment, will have a relapse or progression.
Circulating tumor cells (CTCs), which shed from the primary tumor into the vasculature or lymphatics, can be regarded as a new prognostic factors of metastatic process. Thus far, CTCs-detection technologies can be divided into epithelial cell adhesion molecule (EpCAM)-based detection methods, e.g., the widely used CellSearch® and Adnatest®,and EpCAM-independent detection methods, e.g., ISET® and ScreenCell®. Herein, the investigators used a newly established approach, i.e., CanPatrolTM to detect CTCs in early stage lung Adenocarcinoma cases.
The investigator aim to explore whether CTCs detection prior to surgery can be contributive to the early diagnosis, or may help to predict the prognosis and guide the treatment strategy of early stage lung Adenocarcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stage I lung adenocarcinoma
排除标准
- •cases with any new adjuvant treatment prior to surgery
研究组 & 干预措施
IA-CTC-High-enhance
IA lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy&lymphadenectomy plus adjuvant chemotherapy. Postoperative CTC monitoring will be conducted.
干预措施: lobectomy (Procedure)
IA-CTC-High-enhance
IA lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy&lymphadenectomy plus adjuvant chemotherapy. Postoperative CTC monitoring will be conducted.
干预措施: chemotherapy（pemetrexed+CISPLATIN） (Drug)
IA-CTC-High-enhance
IA lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy&lymphadenectomy plus adjuvant chemotherapy. Postoperative CTC monitoring will be conducted.
干预措施: Lymphadenectomy (Procedure)
IA-CTC-High-enhance
IA lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy&lymphadenectomy plus adjuvant chemotherapy. Postoperative CTC monitoring will be conducted.
干预措施: CanPatrolTM to detect CTCs (Other)
IA-CTC-High-controls
IA lung adenocarcinoma cases with high abundant CTCs prior to operation will only undergo lobectomy&lymphadenectomy. Postoperative CTC monitoring will be conducted.
干预措施: lobectomy (Procedure)
IA-CTC-High-controls
IA lung adenocarcinoma cases with high abundant CTCs prior to operation will only undergo lobectomy&lymphadenectomy. Postoperative CTC monitoring will be conducted.
干预措施: Lymphadenectomy (Procedure)
IA-CTC-High-controls
IA lung adenocarcinoma cases with high abundant CTCs prior to operation will only undergo lobectomy&lymphadenectomy. Postoperative CTC monitoring will be conducted.
干预措施: CanPatrolTM to detect CTCs (Other)
IA-CTC-low-controls
IA lung adenocarcinoma cases with low abundant CTCs prior to operation will only undergo segmentectomy. Postoperative CTC monitoring will be conducted.
干预措施: segmentecomy (Procedure)
IA-CTC-low-controls
IA lung adenocarcinoma cases with low abundant CTCs prior to operation will only undergo segmentectomy. Postoperative CTC monitoring will be conducted.
干预措施: CanPatrolTM to detect CTCs (Other)
IB-CTC-High-enhance
IB lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy&lymphadenectomy plus adjuvant chemotherapy. Postoperative CTC monitoring will be conducted.
干预措施: lobectomy (Procedure)
IB-CTC-High-enhance
IB lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy&lymphadenectomy plus adjuvant chemotherapy. Postoperative CTC monitoring will be conducted.
干预措施: chemotherapy（pemetrexed+CISPLATIN） (Drug)
IB-CTC-High-enhance
IB lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy&lymphadenectomy plus adjuvant chemotherapy. Postoperative CTC monitoring will be conducted.
干预措施: Lymphadenectomy (Procedure)
IB-CTC-High-enhance
IB lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy&lymphadenectomy plus adjuvant chemotherapy. Postoperative CTC monitoring will be conducted.
干预措施: CanPatrolTM to detect CTCs (Other)
IB-CTC-High-controls
IB lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy&lymphadenectomy. Postoperative CTC monitoring will be conducted.
干预措施: lobectomy (Procedure)
IB-CTC-High-controls
IB lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy&lymphadenectomy. Postoperative CTC monitoring will be conducted.
干预措施: Lymphadenectomy (Procedure)
IB-CTC-High-controls
IB lung adenocarcinoma cases with high abundant CTCs prior to operation will undergo lobectomy&lymphadenectomy. Postoperative CTC monitoring will be conducted.
干预措施: CanPatrolTM to detect CTCs (Other)
IB-CTC-low-controls
IB lung adenocarcinoma cases with low abundant CTCs prior to operation will undergo lobectomy&lymphadenectomy. Postoperative CTC monitoring will be conducted.
干预措施: lobectomy (Procedure)
IB-CTC-low-controls
IB lung adenocarcinoma cases with low abundant CTCs prior to operation will undergo lobectomy&lymphadenectomy. Postoperative CTC monitoring will be conducted.
干预措施: Lymphadenectomy (Procedure)
IB-CTC-low-controls
IB lung adenocarcinoma cases with low abundant CTCs prior to operation will undergo lobectomy&lymphadenectomy. Postoperative CTC monitoring will be conducted.
干预措施: CanPatrolTM to detect CTCs (Other)
结局指标
主要结局
Disease free survival
时间窗: From date of diagnosis until the date of first documented progression or date of cancer related death , whichever came first, assessed up to 60 months
次要结局
未报告次要终点
研究者
Deng Bo, MD
Principal Investigator
Third Military Medical University