Recurrent Predictive Power of Circulating Tumor Cells in Non Small Cell Lung Cancer Patients Who Receive Curative Resection
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Validation of variation trend of circulating tumor cell counts
研究概览
简要总结
From literature review, circulating tumor cell was demonstrated its possible role in disease relapse. It was rare nit could be identified in all lung cancer patients. In addition, circulating tumor cell usual aggregate to form circulating tumor micro-emboli and caused distant metastases. Therefore, circulating tumor cell could play a role in detect disease relapse and appropriate treatment could be given more earlier and further prolong patients' survival. However, the detail clinical significance of circulating tumor still remains unknown. The aim of this study was evaluate the clinical significance, including present timing, numbers, and correlation to disease relapse, of circulating tumor cell in lung cancer patients. The investigators want to clarify the clinical significance between circulating tumor cell and clinical presentation of lung cancer in order to establish new prediction model and improve lung cancer patients' survival.
详细描述
Study subject:
Inclusion criteria 1. Patients with clinical stage 1 to 3a non-small lung cancer 2. Patients with a resectable suspicious pulmonary lesion which is difficult for pre-operation tissue prove or refused for pre-operation biopsy 3. Received curative intended tumor resection Exclusion criteria
- Small cell lung cancer component which identified in pathology
- Patients who presented as stage IIIb or IV
- Not received curative intended surgery due to multi-comorbidities
- Patients who presented in tumor seeding or positive resection in pathology confirmation
- Patients who received neoadjuvant therapy
Data collection:
medical record review and blood sampling for circulating tumor cell purification
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-small cell lung cancer patients with stage I to III
- •Patients with resectable suspicious pulmonary malignant lesion
- •no pre-operation diagnosis ( patients refused biopsy or difficult for biopsy)
- •image survey showed clinical stage I to III
排除标准
- •Final pathology coexisted with small cell lung cancer component
- •Patients who presented as stage IIIb or IV.
- •Not received curative intended surgery due to multi-comorbidities.
- •Patients who presented in tumor seeding or positive resection in the final pathology
- •Patients who received neoadjuvant therapy.
结局指标
主要结局
Validation of variation trend of circulating tumor cell counts
时间窗: 1. Circulating tumor cell counts in pre-op, post-op, post-operation day 1 and post-operation day 3 ; 2.model establish model (case 1 to 50) versus validation group ( case 51-120) 3. need complete 5-years surveillance (disease status confirmation)
sequence patient recruitment for validation
Variation trend of circulating tumor cell counts
时间窗: 1. Circulating tumor cell counts in pre-op, post-op, post-operation day 1 and post-operation day 3 ; 2.need complete 5-years surveillance (disease status confirmation)
Relationship between variation trend of circulating tumor cells and disease relapse in patients with a suspicious pulmonary lesion after tumor resection
次要结局
未报告次要终点