A Retrospective Analysis Study on Predicting the Efficacy of Targeted Therapy in Lung Cancer Patients With EGFR Mutations Based on AI-driven Multimodal Data
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- DFS
Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-80 years, undergoing radical surgery for lung cancer (R0 resection);
- •Postoperative pathological stage IB-IIIA, pathology confirmed as adenocarcinoma;
- •EGFR gene testing positive, EGFR 19del/L858R mutation;
- •Receiving postoperative EGFR-TKI targeted adjuvant therapy;
- •Complete and clear preoperative imaging data, genetic testing report, and pathology report available.
Exclusion Criteria
- •Patients negative for EGFR;
- •Incomplete surgical resection (R1, R2);
- •Did not receive EGFR-TKI targeted therapy after surgery;
- •Recurrent or advanced stage patients;
- •Incomplete preoperative or postoperative data;
- •Patients who died within 30 days post-surgery.
Outcomes
Primary Outcomes
DFS
Time Frame: two years
The endpoint of this study was disease-free survival (DFS), defined as the time interval from surgery to the first recurrence or death,assessed up to 24 months。
Secondary Outcomes
No secondary outcomes reported
Investigators
Xiaorong Dong
Professor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology