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NCT05502523 | RECRUITING | Lung Non-Small Cell Carcinoma

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

Thomas Jefferson University

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.

Condition or disease

Lung Non-Small Cell Carcinoma

Stage I Lung Cancer Ajc V8

Stage II Lung Cancer Ajc V8

Stage III Lung Cancer Ajcc v8

Intervention/treatment

Pulmonary Artery-First Surgical Technique

Biospecimen Collection

Phase

NA

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
Estimated Enrollment : 100 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : The Impact of Surgical Technique on Circulating Tumor DNA in Early-Stage Non-Small Cell Lung Cancer
Actual Study Start Date : 2022-08-31
Estimated Primary Completion Date : 2026-01-01
Estimated Study Completion Date : 2029-01-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
The Impact of Surgical Technique on Circulating Tumor DNA in Stage I-III Non-Small Cell Lung Cancer

Location Details

NCT05502523

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How to Participate

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Locations

RECRUITING

United States, Pennsylvania

Abington Memorial Hospital

Abington, Pennsylvania, United States, 19001

RECRUITING

United States, Pennsylvania

Jefferson Health Northeast

Philadelphia, Pennsylvania, United States, 19107

RECRUITING

United States, Pennsylvania

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States, 19107

RECRUITING

United States, Pennsylvania

Asplundh Cancer Pavilion at Jefferson Health

Willow Grove, Pennsylvania, United States, 19090