A Radiomic Model for Risk of Local Recurrence and DFS for T3 and T4 Non-small Cell Lung Cancer

Completed

• Conditions: Lung Cancer, Nonsmall Cell
• Interventions: Other: tumor and peritumor radiomic feature

• Registration Number: NCT06405815
• Lead Sponsor: Jinling Hospital, China

Brief Summary

The investigators retrospectively collected the participants with T3 and T4, N0-2, M0 NSCLC patients resected between January 2013 to December 2021 for training and internal validation. The Clinical data, preoperative laboratory results and images were collected. High-risk margins were defined as R1 or R2 surgical margins or local recurrence during follow-up, and the investigators also collected the disease-free survival time. On the Deepwise multi-modal research platform, the images were semi-automatically segmented and expanded outward by 3mm to obtain the peritumor tissue. PyRadiomics was used to extract the radiomic features. LASSO was used to select the features and tumor radiomics model, peritumor model and combined model were built using 5-fold cross-validation. And it was further tested on the independent cohort. Discrimination was assessed by using the C-index and area under the receiver operating characteristic curve (AUC), sensibility, specificity.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-05
• Study First Submitted: 2024-05-04
• Study First Submitted QC: 2024-05-04
• Last Update Submitted: 2024-05-07
• Study First Posted: 2024-05-08
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• patients with T3 and T4 stage NSCLC；
• available preoperative chest CTE within two weeks of surgery

Exclusion Criteria

• inadequate imaging quality resulted from breathing artifact;
• without regularly follow-up information on recurrence location and time

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
high-risk surgical margin	tumor and peritumor radiomic feature	High-risk margins were defined as R1 or R2 surgical margins or local recurrence during follow-up.
Low-risk surgical margin	tumor and peritumor radiomic feature	Low-risk margins were defined as R0 surgical margin meanwhile arising distant metastasis during follow-up.

Primary Outcome Measures

Name	Time	Method
disease free time and recurrence location	until the December 2023	the time from the surgery time to the recurrence time

Trial Locations

Locations (1)

Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China