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

NCT05502523 | Recruiting

• 2 other identifiers: 22D.435JT 19625
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (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 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 Outcomes (2)

• Disease free survival rate

  Up to 5 years

• Overall survival rate

  Up to 5 years

Study Arms (2)

Group I (pulmonary vein first approach procedure)

ACTIVE COMPARATOR

Patients undergo pulmonary vein first approach surgical procedure on day of surgery.

Procedure: Pulmonary Artery-First Surgical Technique

Group II (pulmonary artery first surgical procedure)

ACTIVE COMPARATOR

Patients undergo pulmonary artery first approach surgical procedure on day of surgery.

Procedure: Biospecimen Collection

Interventions

Pulmonary Artery-First Surgical Technique PROCEDURE

Undergo pulmonary artery first surgical technique

Also known as: Artery-First Technique, A-First Technique, Lung Cancer Artery-First Surgical Technique, Artery-First Surgical Technique, Artery-First Ligation

Group I (pulmonary vein first approach procedure)

Biospecimen Collection PROCEDURE

Correlative studies

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Group II (pulmonary artery first surgical procedure)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (4)

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

RECRUITING

Jefferson Health Northeast

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Asplundh Cancer Pavilion at Jefferson Health

Willow Grove, Pennsylvania, 19090, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Tyler Grenda, MD

  TJU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tyler Grenda, MD

CONTACT

215-955-5562; Tyler.grenda@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 16, 2022
• Study Start: August 31, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

US (4)