NCT07287904

Prediction of Targeted Therapy Efficacy in EGFR-mutant Lung Cancer Patients Using AI-based Multimodal Data

A Retrospective Analysis Study on Predicting the Efficacy of Targeted Therapy in Lung Cancer Patients With EGFR Mutations Based on AI-driven Multimodal Data

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to explore the value of multimodal imaging information and models in predicting the prognosis of EGFR-positive non-small cell lung cancer patients undergoing targeted therapy, providing a basis for selecting suitable populations for precise tumor treatment and corresponding therapy. We retrospectively analyzed patient case data, extracted preoperative CT images, H\&E-stained whole-slide digital pathology images, and pre- or postoperative genetic testing reports to extract radiomic features of tumor and peritumoral regions. These features were combined with multidimensional pathological features and gene expression distribution characteristics to construct a multimodal radiopathogenomic model, offering more precise prognostic evaluation for lung cancer patients receiving targeted therapy.

Detailed description

This study is an observational study, aiming to retrospectively include data from 500 patients diagnosed with stage IB-IIIA invasive lung adenocarcinoma who underwent radical surgery at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, from January 2021 to December 2024, along with data from a total of 1,000 patients from other multi-center sites. The study will collect and record information on subjects' demographics, pathology, imaging, genetic testing, and clinical characteristics via the hospital's electronic medical record system. Patient survival status will be obtained through telephone follow-ups and home visits. Radiomic features of the tumor and peritumoral regions will be extracted from preoperative CT images, H\&E-stained digital whole-slide pathology images, and genetic testing reports. These will be combined with multi-dimensional pathological features and gene expression distribution characteristics from the patient cases to construct a multi-omics model integrating imaging, pathology, demographics, and genetics, providing a more precise prognostic assessment for targeted therapy in lung cancer patients.

Conditions

• Lung Cancer (NSCLC)
• EGFR Activating Mutation
• Adenocarcinoma Lung
• Postoperative Adjuvant Therapy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Comprehensive analysis through laboratory tests, imaging techniques, and clinical data	Extract radiomics features of the tumor and peritumoral regions from preoperative CT images, H\&E-stained digital pathology whole-slide images, and genetic test reports, and integrate them with multidimensional pathological features and gene expression distribution characteristics to construct a radiopathogenomic multi-omics modality, providing more precise prognostic assessment for targeted therapy in lung cancer patients.

Timeline

• Start date: 2025-12-25
• Primary completion: 2027-07-01
• Completion: 2027-08-01
• First posted: 2025-12-17
• Last updated: 2025-12-17

Locations

1 site across 1 country: China