Langue and Imaging-integrated Foundation Model for Gastric Cancer Detection and Staging Via Contrast-Enhanced CT: a Multicenter Study
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY
Accurate preoperative assessment of gastric cancer stage guides eligibility for endoscopic resection, extent of gastrectomy and lymphadenectomy, selection for neoadjuvant therapy, and use of staging laparoscopy. Contrast-enhanced CT (CECT) is guideline-endorsed for initial staging, yet performance varies across institutions and readers. This study will evaluate an artificial-intelligence (AI) system that analyzes routine CECT to detect gastric cancer and assign four-class T stage (T1-T4) and N stage (N0-N3) .
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• pathologically confirmed gastric cancer;
• preoperative contrast-enhanced CT performed;
• no evidence of distant metastasis on baseline staging;
• curative-intent management with complete postoperative histopathology.
Locations
Other Locations
China
The First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Zhang Yudong, PHD, MD
zhangyd3895@njmu.edu.cn
+8618251966069
Backup
Qiong Li
njmu_lq@163.com
+8618351977281
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 8000
Treatments
Cohort 1 (Internal Derivation Cohort)
Retrospective case-only cohort of adults with pathologically confirmed gastric cancer who underwent preoperative contrast-enhanced CT at the sponsoring institution. Existing CT images and clinical/pathology records will be used to train and test the AI model and to estimate diagnostic performance for T and N staging.
Cohort 2 (External Validation Cohort A)
Independent retrospective case-only cohort from an external hospital with the same inclusion/exclusion criteria. Used solely for external validation to assess reproducibility across sites and scanners.
Cohort 3 (External Validation Cohort B)
A second independent retrospective validation cohort from another institution to further test generalizability.
Related Therapeutic Areas
Sponsors
Collaborators: The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Peking University First Hospital, Jiangsu Cancer Institute & Hospital
Leads: The First Affiliated Hospital with Nanjing Medical University