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AI-Assisted Novel rbcDNA Detection for Early Gastric Cancer Diagnosis
Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
Summary
The goal of this clinical trial is to prospectively validate the diagnostic performance of an rbcDNA-based assay for gastric cancer detection in individuals undergoing upper gastrointestinal endoscopy. The study aims to evaluate the diagnostic accuracy of rbcDNA in distinguishing newly diagnosed, treatment-naïve gastric cancer from non-cancerous gastric conditions, using endoscopic and histopathological findings as the reference standard. The study will also compare the diagnostic performance of the rbcDNA-based approach with currently available clinical biomarkers, including serum tumor markers, Helicobacter pylori testing, and pepsinogen-related indices. All enrolled participants will provide a 2 mL peripheral blood sample for rbcDNA analysis.
Official title: Application Research of Artificial Intelligence-Assisted Novel Red Blood Cell DNA (rbcDNA) Detection for Early Diagnosis of Gastric Cancer
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
542
Start Date
2026-09-01
Completion Date
2027-12-31
Last Updated
2026-08-24
Healthy Volunteers
No
Conditions
Locations (3)
Anyang Tumor Hospital
Anyang, Henan, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China