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

Thomas Jefferson University

Status: Enrolling

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

Treatments: Procedure: Biospecimen Collection; Procedure: Pulmonary Artery-First Surgical Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT05502523

22D.435

JT 19625 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Group I (pulmonary vein first approach procedure)

Active Comparator group

Description:

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

Treatment:

Procedure: Pulmonary Artery-First Surgical Technique

Group II (pulmonary artery first surgical procedure)

Active Comparator group

Description:

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

Treatment:

Procedure: Biospecimen Collection