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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Non-Small Cell Carcinoma; Stage III Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Stage I Lung Cancer AJCC v8
• Intervention / Treatment: Procedure: Biospecimen Collection; Procedure: Pulmonary Artery-First Surgical Technique

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

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tyler Grenda, MD; Phone Number: 215-955-5562; Email: tyler.grenda@jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Recruiting
      • Abington Memorial Hospital
      • Contact: Mary Walicki, RN; Phone Number: 215-481-5528; Email: mary.walicki@jefferson.edu
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University Hospital
      • Contact: Tyler Grenda, MD; Phone Number: 215-955-5562; Email: tyler.grenda@jefferson.edu
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Jefferson Health Northeast
      • Contact: Joanne Anderson; Phone Number: 215-866-8690
    • Willow Grove, Pennsylvania, United States, 19090
      • Recruiting
      • Asplundh Cancer Pavilion at Jefferson Health
      • Contact: John Jacob, MD; Phone Number: 215-481-4000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I (pulmonary vein first approach procedure); Patients undergo pulmonary vein first approach surgical procedure on day of surgery.	Procedure: Pulmonary Artery-First Surgical Technique; 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
Active Comparator: Group II (pulmonary artery first surgical procedure); Patients undergo pulmonary artery first approach surgical procedure on day of surgery.	Procedure: Biospecimen Collection; Correlative studies; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	At postoperative day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 5 years

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: Tyler Grenda, MD, TJU

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling
• Other Study ID Numbers: 22D.435; JT 19625 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No