The Impact of Surgical Technique on Circulating Tumor DNA in Early-Stage Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Circulating tumor deoxyribonucleic acid (ctDNA) status
研究概览
简要总结
This clinical trial compares the effect of pulmonary vein-first surgical technique to pulmonary artery-first surgical technique in decreasing circulating tumor cell deoxyribonucleic acid (ctDNA) in patients with stage I-III non-small cell lung cancer. Pulmonary vein first and pulmonary artery first surgical techniques are standard surgical techniques for the division of the blood vessels during lung resection surgery. Pulmonary vein-first surgical technique may reduce the risk of shedding tumor cells during surgery and influence long term overall survival.
详细描述
PRIMARY OBJECTIVE:
I. To determine the association between sequence of surgical resection and postoperative ctDNA levels at specified time points.
SECONDARY OBJECTIVE:
I. To determine the associated between sequence of surgical resection and postoperative ctDNA level and clinical oncologic outcomes.
II. To assess disease-free survival and the role of circulating tumor DNA in disease recurrence in patients with resectable non-small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Any patients 18 years of age or older with confirmed or suspected early-stage (stage I-III) NSCLC
- •Eligible and scheduled for surgical anatomic lung resection (e.g. lobectomy or segmentectomy) as routine clinical care for their disease
排除标准
- •Previous cancer diagnosis within 5 years (except ductal carcinoma in situ [DCIS] of the breast, superficial bladder cancer, non-melanoma skin primary, other malignancy that does not require treatment).
- •Preoperative chemotherapy, immunotherapy, or radiation therapy
- •Receipt of perioperative blood transfusion
研究组 & 干预措施
Group I (pulmonary vein first approach procedure)
Patients undergo pulmonary vein first approach surgical procedure on day of surgery.
干预措施: Pulmonary Artery-First Surgical Technique (Procedure)
Group II (pulmonary artery first surgical procedure)
Patients undergo pulmonary artery first approach surgical procedure on day of surgery.
干预措施: Biospecimen Collection (Procedure)
结局指标
主要结局
Circulating tumor deoxyribonucleic acid (ctDNA) status
时间窗: At postoperative day 14
Stratified by surgical vascular division technique. A peripheral blood sample will be taken at the time of surgery to determine baseline ctDNA status. Following surgical resection a blood sample will be taken at specified time points (postoperative day 2; postoperative day 14) to determine ctDNA levels compared to baseline. The difference in the proportion of patients who have positive ctDNA status between those undergoing division/ligation in a "pulmonary-vein first" technique compared to a "pulmonary-artery first" technique will be estimated. The risk difference will be estimated along with a 95% confidence interval.
Circulating tumor deoxyribonucleic acid (ctDNA) status
时间窗: At postoperative day 2
Stratified by surgical vascular division technique. A peripheral blood sample will be taken at the time of surgery to determine baseline ctDNA status. Following surgical resection a blood sample will be taken at specified time points (postoperative day 2; postoperative day 14) to determine ctDNA levels compared to baseline. The difference in the proportion of patients who have positive ctDNA status between those undergoing division/ligation in a "pulmonary-vein first" technique compared to a "pulmonary-artery first" technique will be estimated. The risk difference will be estimated along with a 95% confidence interval.
次要结局
- Disease free survival rate(Up to 5 years)
- Overall survival rate(Up to 5 years)