Lung Cancer (NSCLC)NCT07552532
Multimodal CT-Based Risk Stratification for Postoperative Local Recurrence in NSCLC: A Multicenter Study
An observational study of Lung Cancer (NSCLC), run by Guangming Lu at 1 site in China.
Trial summary
This multicenter retrospective study is designed to develop and validate a CT-based multimodal risk stratification approach for postoperative local recurrence after curative-intent resection of non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (NSCLC)
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Jun 2026
- Phase
- Observational
- 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
Study population: Patients with pathologically confirmed non-small cell lung cancer (NSCLC) who underwent curative-intent surgical resection and had preoperative contrast-enhanced chest CT available were retrospectively identified from participating centers. Eligible patients had complete clinicopathological, imaging, and follow-up data for assessment of postoperative local recurrence.
Who may be able to join
- Pathologically confirmed non-small cell lung cancer (NSCLC)
- Preoperative contrast-enhanced chest CT performed within 2 weeks before surgery
- Underwent routine postoperative follow-up
Who cannot join
- Small cell lung cancer or metastatic tumors
- Incomplete resection (R1/R2)
- No preoperative contrast-enhanced CT performed within 2 weeks before surgery
- History of other malignancies
- Inadequate follow-up or follow-up duration of 3 months or less
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multimodal CT-Based Risk Stratification of Postoperative Local Recurrence in Non-Small Cell Lung Cancer: A Multicenter Study
This multicenter retrospective study is designed to develop and validate a CT-based multimodal risk stratification approach for postoperative local recurrence after curative-intent resection of non-small cell lung cancer (NSCLC). The approach integrates clinicopathologic variables, intratumoral and peritumoral radiomics, tumor-based 2.5D deep learning features, whole-lung deep learning features, and operative text features to capture complementary information related to tumor phenotype, pulmonary background, and surgical findings. Predictive performance and clinical utility will be evaluated in internal and external validation cohorts using the concordance index, time-dependent area under the receiver operating characteristic curve, decision curve analysis, and risk reclassification analyses. The objective of this study is to assess whether multimodal CT-based risk stratification may improve postoperative risk assessment and support individualized surveillance and management strategies.
- Conditions
- Lung Cancer (NSCLC)
- Keywords
- local recurrence, risk stratification, radiomics, deep learning
- Medical subject headings
- Lung Neoplasms, 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 |
|---|---|---|
| local recurrence after surgery | The primary endpoint was postoperative local recurrence, defined as recurrence within the ipsilateral hemithorax, including the bronchial stump or parenchymal margin, ipsilateral hilar or mediastinal lymph nodes, and pleural or chest wall seeding. Local recurrence was primarily determined by serial imaging assessment, with PET/CT and pathology used when necessary. To distinguish recurrence from a new primary lung cancer, lesion location, imaging features, histology, and timing were considered comprehensively. | |
| non-local recurrence | stable or distant metastasis or death during follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative local recurrence
Measured: From the date of surgery to first documented local recurrence, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start1 Jan 2023
- Primary completion1 Feb 2026
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- 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
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangming Lu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guangming Lu, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552532
- Sponsor's protocol ID
- 2025-DZLC-03
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal CT-Based Risk Stratification of Postoperative Local Recurrence in Non-Small Cell Lung Cancer: A Multicenter Study
- ClinicalTrials.gov ID
- NCT07552532
- Acronym / sponsor ID
- 2025-DZLC-03
- Conditions
- Lung Cancer (NSCLC)
- Keywords
- local recurrence, risk stratification, radiomics, deep learning
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Guangming LuUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 27 Apr 2026 (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 multicenter retrospective study is designed to develop and validate a CT-based multimodal risk stratification approach for postoperative local recurrence after curative-intent resection of non-small cell lung cancer (NSCLC). The approach integrates clinicopathologic variables, intratumoral and peritumoral radiomics, tumor-based 2.5D deep learning features, whole-lung deep learning features, and operative text features to capture complementary information related to tumor phenotype, pulmonary background, and surgical findings. Predictive performance and clinical utility will be evaluated in internal and external validation cohorts using the concordance index, time-dependent area under the receiver operating characteristic curve, decision curve analysis, and risk reclassification analyses. The objective of this study is to assess whether multimodal CT-based risk stratification may improve postoperative risk assessment and support individualized surveillance and management strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| local recurrence after surgery | – | –The primary endpoint was postoperative local recurrence, defined as recurrence within the ipsilateral hemithorax, including the bronchial stump or parenchymal margin, ipsilateral hilar or mediastinal lymph nodes, and pleural or chest wall seeding. Local recurrence was primarily determined by serial imaging assessment, with PET/CT and pathology used when necessary. To distinguish recurrence from a new primary lung cancer, lesion location, imaging features, histology, and timing were considered comprehensively. |
| non-local recurrence | – | –stable or distant metastasis or death during follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pathologically confirmed non-small cell lung cancer (NSCLC) who underwent curative-intent surgical resection and had preoperative contrast-enhanced chest CT available were retrospectively identified from participating centers. Eligible patients had complete clinicopathological, imaging, and follow-up data for assessment of postoperative local recurrence.
Key inclusion criteria (3 listed)
- Pathologically confirmed non-small cell lung cancer (NSCLC)
- Preoperative contrast-enhanced chest CT performed within 2 weeks before surgery
- Underwent routine postoperative follow-up
Key exclusion criteria (5 listed)
- Small cell lung cancer or metastatic tumors
- Incomplete resection (R1/R2)
- No preoperative contrast-enhanced CT performed within 2 weeks before surgery
- History of other malignancies
- Inadequate follow-up or follow-up duration of 3 months or less
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
Postoperative local recurrence
Time frame: From the date of surgery to first documented local recurrence, up to 3 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 27 Apr 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lung Cancer (NSCLC), run by Guangming Lu 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. 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?
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?
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?
Postoperative local recurrence (time frame: From the date of surgery to first documented local recurrence, up to 3 years). 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 27 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.