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Clinical Trials/NCT07552532
NCT07552532Active, not recruitingNot Applicable

Multimodal CT-Based Risk Stratification of Postoperative Local Recurrence in Non-Small Cell Lung Cancer: A Multicenter Study

Guangming Lu1 site in 1 country2,000 target enrollmentStarted: January 1, 2023Last updated:
Conditions

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

Sponsor
Guangming Lu
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Guangming Lu

Professor

Jinling Hospital, China

Study Sites (1)

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