- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07552532
Multimodal CT-Based Risk Stratification for Postoperative Local Recurrence in NSCLC: A Multicenter Study
April 20, 2026 updated by: Guangming Lu
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.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Observational
Enrollment (Actual)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Jiangsu
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Nanjing, Jiangsu, China, 210002
- Jinling Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- Pathologically confirmed non-small cell lung cancer (NSCLC)
- Preoperative contrast-enhanced chest CT performed within 2 weeks before surgery
- Underwent routine postoperative follow-up
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Postoperative local recurrence
Time Frame: From the date of surgery to first documented local recurrence, up to 3 years
|
From the date of surgery to first documented local recurrence, up to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Actual)
February 1, 2026
Study Completion (Estimated)
June 1, 2026
Study Registration Dates
First Submitted
April 14, 2026
First Submitted That Met QC Criteria
April 20, 2026
First Posted (Actual)
April 27, 2026
Study Record Updates
Last Update Posted (Actual)
April 27, 2026
Last Update Submitted That Met QC Criteria
April 20, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-DZLC-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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