NCT Number: NCT05502523
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Abington Memorial Hospital, Abington, Pennsylvania, United States
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo pulmonary artery first surgical technique
Other names: Artery-First Technique, A-First Technique, Lung Cancer Artery-First Surgical Technique, Artery-First Surgical Technique, Artery-First Ligation
Correlative studies
Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Time frame: 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.
Time frame: 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.
Time frame: Up to 5 years
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
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.
Contact information is provided by the study sponsor or research team.
Thomas Jefferson University
Other
The Impact of Surgical Technique on Circulating Tumor DNA in Early-Stage Non-Small Cell Lung Cancer
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