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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThomas Jefferson University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Pulmonary Artery-First Surgical Technique

    Procedure/Surgery

    Undergo pulmonary artery first surgical technique

  • Biospecimen Collection

    Procedure/Surgery

    Correlative studies

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Group I (pulmonary vein first approach procedure)Active comparator 1 intervention
Group B: Group II (pulmonary artery first surgical procedure)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At postoperative day 2
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.

Time frame
At postoperative day 14

Secondary outcomes

1

Disease free survival rate

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.

Time frame
Up to 5 years
2

Overall survival rate

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.

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

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