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NCT05502523NARecruiting

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

Thomas Jefferson University

Start Date

8/31/2022

Completion Date

1/1/2029

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

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Interventions

PROCEDURE

Pulmonary Artery-First Surgical Technique

PROCEDURE

Biospecimen Collection

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Conditions

Lung Non-Small Cell CarcinomaStage I Lung Cancer AJCC v8Stage II Lung Cancer AJCC v8Stage III Lung Cancer AJCC v8

Locations

Abington Memorial Hospital

Abington, Pennsylvania 19001

United States

Jefferson Health Northeast

Philadelphia, Pennsylvania 19107

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania 19107

United States

Asplundh Cancer Pavilion at Jefferson Health

Willow Grove, Pennsylvania 19090

United States