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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-31

Study Completion Date

2029-01-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group I (pulmonary vein first approach procedure)

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

Group Type ACTIVE_COMPARATOR

Pulmonary Artery-First Surgical Technique

Intervention Type PROCEDURE

Undergo pulmonary artery first surgical technique

Group II (pulmonary artery first surgical procedure)

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

Group Type ACTIVE_COMPARATOR

Biospecimen Collection

Intervention Type PROCEDURE

Correlative studies

Interventions

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Pulmonary Artery-First Surgical Technique

Undergo pulmonary artery first surgical technique

Intervention Type PROCEDURE

Biospecimen Collection

Correlative studies

Intervention Type PROCEDURE

Other Intervention Names

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Artery-First Technique A-First Technique Lung Cancer Artery-First Surgical Technique Artery-First Surgical Technique Artery-First Ligation Biological Sample Collection Biospecimen Collected Specimen Collection

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No