Multimodal CT-Based Risk Stratification of Postoperative Local Recurrence in Non-Small Cell Lung Cancer: A Multicenter Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 2,000
- Locations
- 1
- Primary Endpoint
- Postoperative local recurrence
Study Overview
Brief 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). 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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Outcomes
Primary Outcomes
Postoperative local recurrence
Time Frame: From the date of surgery to first documented local recurrence, up to 3 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Guangming Lu
Professor
Jinling Hospital, China
