AI-Assisted Novel rbcDNA Detection for Early Gastric Cancer Diagnosis

Application Research of Artificial Intelligence-Assisted Novel Red Blood Cell DNA (rbcDNA) Detection for Early Diagnosis of Gastric Cancer

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.

Inclusion Criteria

• Age between 18 and 75 years.
• Scheduled for upper gastrointestinal endoscopy for the assessment of gastric diseases, including gastric cancer (stage I-IV), gastric precancerous lesions, and other benign gastric disorders.
• No previous treatment for the current gastric disease prior to blood collection, including surgery, chemotherapy, radiotherapy, immunotherapy and other anti-tumor therapies.
• Able and willing to participate and provide written informed consent. Exclusion Criteria
• Receiving therapeutic gastroscopy or endoscopic resection for gastric lesions diagnosed in other institutions.
• Presence of conditions that hinder complete gastric endoscopic visualization and reliable lesion evaluation, such as gastric retention and severe esophageal stenosis.
• History of other malignant tumors, prior anti-tumor treatment, or partial/total gastrectomy.
• Severe hemodynamic instability, malignant arrhythmia, unstable cardiovascular diseases, or recent major surgery.
• Hematological disorders, recent blood transfusion history, severe active infection, chronic infectious diseases (e.g., HIV), or severe systemic inflammation affecting blood cell composition.
• Pregnant or breastfeeding women.
• Enrolled in other concurrent clinical trials that may affect the current study results.
• Refusal to sign informed consent or failure to comply with study procedures.