An interventional study of Pulmonary Artery-First Surgical Technique and Biospecimen Collection in Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8 and Stage II Lung Cancer AJCC v8, sponsored by Thomas Jefferson University. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Thomas Jefferson University · Not applicable, Interventional, and Treatment
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.
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.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo pulmonary vein first approach surgical procedure on day of surgery.
GROUP II: Patients undergo pulmonary artery first approach surgical procedure on day of surgery.
After completion of surgery, patients are followed up at day 1, day 7, days 7-28, 4 months, every 6 months for 2 years, then every 6 months for up to 5 years
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 100 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
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Exclusion Criteria:
Patients undergo pulmonary vein first approach surgical procedure on day of surgery.
Procedure: Pulmonary Artery-First Surgical Technique
Patients undergo pulmonary artery first approach surgical procedure on day of surgery.
Procedure: Biospecimen Collection
Undergo pulmonary artery first surgical technique
Also known as: Artery-First Technique, A-First Technique, Lung Cancer Artery-First Surgical Technique, Artery-First Surgical Technique, Artery-First Ligation
Correlative studies
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Circulating tumor deoxyribonucleic acid (ctDNA) status
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.
Time frame: At postoperative day 2
Circulating tumor deoxyribonucleic acid (ctDNA) status
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.
Time frame: At postoperative day 14
Disease free survival rate
The distribution of survival outcomes will be estimated using the Kaplan-Meier method, stratified by ctDNA status at 2 days and 2 weeks. Key statistics (median survival, 1- and 2-year survival) will be estimated from the curve along with 95% confidence intervals. We will also use a Cox proportional hazard regression model, stratified by stage in the analyses, to estimate the hazard ratio along with a 95% confidence interval.
Time frame: Up to 5 years
Overall survival rate
The distribution of survival outcomes will be estimated using the Kaplan-Meier method, stratified by ctDNA status at 2 days and 2 weeks. Key statistics (median survival, 1- and 2-year survival) will be estimated from the curve along with 95% confidence intervals. We will also use a Cox proportional hazard regression model, stratified by stage in the analyses, to estimate the hazard ratio along with a 95% confidence interval.
Time frame: Up to 5 years
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