Multimodal CT-Based Risk Stratification for Postoperative Local Recurrence in NSCLC: A Multicenter Study

NCT07552532 | Active Not Recruiting DMC

• 1 other identifier: 2025-DZLC-03
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer (NSCLC)

Keywords

local recurrence; risk stratification; radiomics; deep learning

Outcome Measures

Primary Outcomes (1)

• Postoperative local recurrence

  From the date of surgery to first documented local recurrence, up to 3 years

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Pathologically confirmed non-small cell lung cancer (NSCLC)
• Preoperative contrast-enhanced chest CT performed within 2 weeks before surgery
• Underwent routine postoperative follow-up

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangming Lu: lead

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 27, 2026
• Study Start: January 1, 2023
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)