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NCT07782294 · ClinicalTrials.gov record · last posted 2026-08-24

AI-Assisted Novel rbcDNA Detection for Early Gastric Cancer Diagnosis

StatusNot Yet Recruiting
PhaseNot specified
Started2026-09-01
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from the ClinicalTrials.gov record
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.
Trial Details
NCT Number NCT07782294
Lead Sponsor Second Affiliated Hospital, Zhejiang University, School of Medicine
Collaborators: Anyang Tumor Hospital, RenJi Hospital
Conditions Gastric Cancer
Enrollment 542 participants
Start Date 2026-09-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-24