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Recruiting NCT05502523

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

No phase Interventional Lung Non-Small Cell Carcinoma Stage I Lung Cancer AJCC v8 Stage II Lung Cancer AJCC v8 Stage III Lung Cancer AJCC v8

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pulmonary Artery-First Surgical Technique, Biospecimen Collection.
Who it may be relevant to
Registry conditions: Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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

Interventions

  • Procedure Pulmonary Artery-First Surgical Technique
    Undergo pulmonary artery first surgical technique
  • Procedure Biospecimen Collection
    Correlative studies

Primary outcome measures

  • Circulating tumor deoxyribonucleic acid (ctDNA) status [Time frame: At postoperative day 2]
  • Circulating tumor deoxyribonucleic acid (ctDNA) status [Time frame: At postoperative day 14]
Secondary outcome measures (2)
  • Disease free survival rate [Time frame: Up to 5 years]
  • Overall survival rate [Time frame: Up to 5 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • Abington Memorial Hospital — Abington
  • Jefferson Health Northeast — Philadelphia
  • Thomas Jefferson University Hospital — Philadelphia
  • Asplundh Cancer Pavilion at Jefferson Health — Willow Grove

Identifiers

NCT: NCT05502523 · 22D.435 · JT 19625

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗