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Trial Title:
The Impact of Surgical Technique on Circulating Tumor DNA in Stage I-III Non-Small Cell Lung Cancer
NCT ID:
NCT05502523
Condition:
Lung Non-Small Cell Carcinoma
Stage I Lung Cancer AJCC v8
Stage II Lung Cancer AJCC v8
Stage III Lung Cancer AJCC v8
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
N/A
Overall status:
Suspended
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Pulmonary Artery-First Surgical Technique
Description:
Undergo pulmonary artery first surgical technique
Arm group label:
Group I (pulmonary vein first approach procedure)
Other name:
Artery-First Technique
Other name:
A-First Technique
Other name:
Lung Cancer Artery-First Surgical Technique
Other name:
Artery-First Surgical Technique
Other name:
Artery-First Ligation
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Correlative studies
Arm group label:
Group II (pulmonary artery first surgical procedure)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
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.
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Abington Memorial Hospital
Address:
City:
Abington
Zip:
19001
Country:
United States
Facility:
Name:
Jefferson Health Northeast
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Facility:
Name:
Thomas Jefferson University Hospital
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Start date:
August 31, 2022
Completion date:
January 1, 2029
Lead sponsor:
Agency:
Thomas Jefferson University
Agency class:
Other
Source:
Thomas Jefferson University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05502523
