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Brief Title: The Impact of Surgical Technique on Circulating Tumor DNA in Stage I-III Non-Small Cell Lung Cancer
Official Title: The Impact of Surgical Technique on Circulating Tumor DNA in Early-Stage Non-Small Cell Lung Cancer
Study ID: NCT05502523
Brief 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Name: Tyler Grenda, MD
Affiliation: TJU
Role: PRINCIPAL_INVESTIGATOR