NCT05502523

The Impact of Surgical Technique on Circulating Tumor DNA in Stage I-III Non-Small Cell Lung Cancer

The Impact of Surgical Technique on Circulating Tumor DNA in Early-Stage Non-Small Cell Lung Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Lung Non-Small Cell Carcinoma
• Stage I Lung Cancer AJCC v8
• Stage II Lung Cancer AJCC v8
• Stage III Lung Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Pulmonary Artery-First Surgical Technique	Undergo pulmonary artery first surgical technique
PROCEDURE	Biospecimen Collection	Correlative studies

Timeline

• Start date: 2022-08-31
• Primary completion: 2027-01-01
• Completion: 2029-01-01
• First posted: 2022-08-16
• Last updated: 2026-01-23

Locations

4 sites across 1 country: United States