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

January 21, 2026 updated by: Thomas Jefferson University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Contact:
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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.
At postoperative day 2
Circulating tumor deoxyribonucleic acid (ctDNA) status
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.
At postoperative day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival rate
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.
Up to 5 years
Overall survival rate
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.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Investigators

  • Principal Investigator: Tyler Grenda, MD, TJU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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