Non-Small Cell Lung CancerNCT07005401
Factors Determine the Feasibility and Surgical Margin Quality of Sublobar Resection for Non-small Cell Lung Cancer?
An observational study of Non-Small Cell Lung Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Sublobar resection (SR) has been recognized as non-inferior to lobectomy for small-sized non-small cell lung cancer (NSCLC). This study aimed to systematically identify the potential factors influencing the feasibility and surgical margin quality of SR for small-sized NSCLC. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Small Cell Lung Cancer
- How many people
- 1,064 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with small-sized pulmonary nodules who underwent lobectomy or sublobar resection between 2020 and 2023 in a single surgical team were retrospectively screened.
Who may be able to join
- the maximum nodule diameter ≤ 2 cm
- single malignant nodule
- intentional resection
- histopathological confirmed primary non-small cell lung cancer
Who cannot join
- interlobar lesions
- nodules located in the right middle lobe
- receiving neoadjuvant before surgery
- poor CT quality were excluded
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: What Determines the Feasibility and Surgical Margin Quality of Sublobar Resection for Small-sized Non-small Cell Lung Cancer?
Sublobar resection (SR) has been recognized as non-inferior to lobectomy for small-sized non-small cell lung cancer (NSCLC). This study aimed to systematically identify the potential factors influencing the feasibility and surgical margin quality of SR for small-sized NSCLC.
Patients with small-sized NSCLC (≤2 cm) who underwent SR or lobectomy between 2020 and 2023 were screened. Surgical procedures were determined by discussion under the guidance of 3D-CTBA. A surgical margin ≥ the maximum tumor diameter was considered sufficient. SR with a sufficient surgical margin was considered eligible. Univariate and multivariate logistic regression analyses were performed to identify factors affecting the feasibility and margin quality of SR.
Read the detailed description
Patients with small-sized pulmonary nodules who underwent lobectomy or SR between 2020 and 2023 in a single surgical team were retrospectively screened. All the surgical approach was jointly determined by three experienced surgeons (at least 15 years, Doctor Liang Chen, Weibing Wu and Zhicheng He). Patients satisfied with the following criteria were initially reserved: (1) the maximum nodule diameter ≤ 2 cm; (2) single malignant nodule; (3) intentional resection; (4) histopathological confirmed primary NSCLC. Further, patients with (1) interlobar lesions; (2) nodules in the right middle lobe; (3) receiving neoadjuvant before surgery; (4) poor CT quality were excluded.
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer, Segmentectomy, Wedge resection, Margin quality
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing eligible sublobar resection | A surgical margin ≥ the maximum tumor diameter was considered sufficient. Sublobar resection with a sufficient surgical margin was considered eligible. | |
| Patients undergoing lobectomy or ineligible sublobar resection | Patients who underwent lobectomy or received ineligible sublobar resection (sublobar resection with an insufficient surgical margin: less than the maximum tumor diameter) |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical margin quality
A surgical margin ≥ the maximum tumor diameter was considered sufficient.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Jan 2020
- Primary completion31 May 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,064 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Chen, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Liang Chen, MD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005401
- Sponsor's protocol ID
- TSCI 002
- Status last verified
- May 2025
- First submitted
- 27 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Determines the Feasibility and Surgical Margin Quality of Sublobar Resection for Small-sized Non-small Cell Lung Cancer?
- ClinicalTrials.gov ID
- NCT07005401
- Acronym / sponsor ID
- TSCI 002
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer, Segmentectomy, Wedge resection, Margin quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,064 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 5 Jun 2025 (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.
Sublobar resection (SR) has been recognized as non-inferior to lobectomy for small-sized non-small cell lung cancer (NSCLC). This study aimed to systematically identify the potential factors influencing the feasibility and surgical margin quality of SR for small-sized NSCLC.
Patients with small-sized NSCLC (≤2 cm) who underwent SR or lobectomy between 2020 and 2023 were screened. Surgical procedures were determined by discussion under the guidance of 3D-CTBA. A surgical margin ≥ the maximum tumor diameter was considered sufficient. SR with a sufficient surgical margin was considered eligible. Univariate and multivariate logistic regression analyses were performed to identify factors affecting the feasibility and margin quality of SR.
Detailed description
Patients with small-sized pulmonary nodules who underwent lobectomy or SR between 2020 and 2023 in a single surgical team were retrospectively screened. All the surgical approach was jointly determined by three experienced surgeons (at least 15 years, Doctor Liang Chen, Weibing Wu and Zhicheng He). Patients satisfied with the following criteria were initially reserved: (1) the maximum nodule diameter ≤ 2 cm; (2) single malignant nodule; (3) intentional resection; (4) histopathological confirmed primary NSCLC. Further, patients with (1) interlobar lesions; (2) nodules in the right middle lobe; (3) receiving neoadjuvant before surgery; (4) poor CT quality were excluded.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing eligible sublobar resection | – | –A surgical margin ≥ the maximum tumor diameter was considered sufficient. Sublobar resection with a sufficient surgical margin was considered eligible. |
| Patients undergoing lobectomy or ineligible sublobar resection | – | –Patients who underwent lobectomy or received ineligible sublobar resection (sublobar resection with an insufficient surgical margin: less than the maximum tumor diameter) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with small-sized pulmonary nodules who underwent lobectomy or sublobar resection between 2020 and 2023 in a single surgical team were retrospectively screened.
Key inclusion criteria (4 listed)
- the maximum nodule diameter ≤ 2 cm
- single malignant nodule
- intentional resection
- histopathological confirmed primary non-small cell lung cancer
Key exclusion criteria (4 listed)
- interlobar lesions
- nodules located in the right middle lobe
- receiving neoadjuvant before surgery
- poor CT quality were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
surgical margin quality
Time frame: Perioperative
A surgical margin ≥ the maximum tumor diameter was considered sufficient.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Liang Chen, MD principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical margin quality (time frame: Perioperative). 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 5 Jun 2025.