Lung Non-Small Cell CarcinomaNCT05502523
The Impact of Surgical Technique on Circulating Tumor DNA in Stage I-III Non-Small Cell Lung Cancer
A study testing Pulmonary Artery-First Surgical Technique and Biospecimen Collection in people with Lung Non-Small Cell Carcinoma and Stage I Lung Cancer AJCC v8, run by Thomas Jefferson University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8
- What is being tested?
- Pulmonary Artery-First Surgical Technique and Biospecimen Collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- 31 Aug 2022to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Abington Memorial Hospital
Abington, Pennsylvania, 19001
Mary Walicki, RN, 215-481-5528, mary.walicki@jefferson.edu
- Recruiting
Jefferson Health Northeast
Philadelphia, Pennsylvania, 19107
Joanne Anderson, 215-866-8690
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Tyler Grenda, MD, 215-955-5562, tyler.grenda@jefferson.edu
- Recruiting
Asplundh Cancer Pavilion at Jefferson Health
Willow Grove, Pennsylvania, 19090
John Jacob, MD, 215-481-4000
About this study
Official title: The Impact of Surgical Technique on Circulating Tumor DNA in Early-Stage Non-Small Cell Lung Cancer
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the association between sequence of surgical resection and postoperative ctDNA levels at specified time points.
SECONDARY OBJECTIVE:
- 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
- Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8
- Being tested
- Pulmonary Artery-First Surgical Technique, Biospecimen Collection
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Artery-First Surgical TechniqueProcedure or surgery
Also called Artery-First Technique, A-First Technique, Lung Cancer Artery-First Surgical Technique, Artery-First Surgical Technique
Undergo pulmonary artery first surgical technique
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (pulmonary vein first approach procedure) | Active comparator | Patients undergo pulmonary vein first approach surgical procedure on day of surgery. Receives: Procedure: Pulmonary Artery-First Surgical Technique |
| Group II (pulmonary artery first surgical procedure) | Active comparator | Patients undergo pulmonary artery first approach surgical procedure on day of surgery. Receives: Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At postoperative day 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.
Measured: At postoperative day 14
Secondary outcomes (2)
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.
Measured: Up to 5 years
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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start31 Aug 2022
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tyler Grenda, MD, Principal investigator, TJU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502523
- Sponsor's protocol ID
- 22D.435
- Other IDs
- JT 19625
- Status last verified
- Jan 2026
- First submitted
- 1 Aug 2022
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Surgical Technique on Circulating Tumor DNA in Early-Stage Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05502523
- Acronym / sponsor ID
- 22D.435
- Conditions
- Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 16 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the association between sequence of surgical resection and postoperative ctDNA levels at specified time points.
SECONDARY OBJECTIVE:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (pulmonary vein first approach procedure) | Active comparator | Procedure: Pulmonary Artery-First Surgical TechniquePatients undergo pulmonary vein first approach surgical procedure on day of surgery. |
| Group II (pulmonary artery first surgical procedure) | Active comparator | Procedure: Biospecimen CollectionPatients undergo pulmonary artery first approach surgical procedure on day of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary Artery-First Surgical TechniqueAlso: Artery-First Technique, A-First Technique, Lung Cancer Artery-First Surgical Technique, Artery-First Surgical TechniqueUndergo pulmonary artery first surgical technique | Procedure or surgery | Group I (pulmonary vein first approach procedure) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionCorrelative studies | Procedure or surgery | Group II (pulmonary artery first surgical procedure) |
Primary outcome
Circulating tumor deoxyribonucleic acid (ctDNA) status
Time frame: At postoperative day 2
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.
Circulating tumor deoxyribonucleic acid (ctDNA) status
Time frame: At postoperative day 14
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.
2 secondary outcomes
Disease free survival rate
Time frame: Up to 5 years
Overall survival rate
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tyler Grenda, MD principal investigator
TJU
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Artery-First Surgical Technique and Biospecimen Collection in people with Lung Non-Small Cell Carcinoma and Stage I Lung Cancer AJCC v8, run by Thomas Jefferson University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tyler Grenda, MD (215-955-5562, Tyler.grenda@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating tumor deoxyribonucleic acid (ctDNA) status (time frame: At postoperative day 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.