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.
Study Type
OBSERVATIONAL
Enrollment
542
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
Sensitivity of the rbcDNA blood test for gastric cancer screening
Sensitivity is defined as the percentage of participants with pathologically confirmed gastric cancer who have a positive rbcDNA test result. Final pathological diagnosis from standard hospital clinical examination serves as the gold-standard reference for calculation. Higher sensitivity indicates fewer true gastric cancer cases are missed by the test.
Time frame: Through study completion, an average of 1 year
Specificity of the rbcDNA blood test for gastric cancer screening
Specificity is defined as the percentage of participants without gastric cancer (with other benign gastric disorders) who have a negative rbcDNA test result. Final pathological diagnosis from standard hospital clinical examination serves as the gold-standard reference for calculation. Higher specificity indicates fewer false-positive test results.
Time frame: Through study completion, an average of 1 year
Overall accuracy of the rbcDNA blood test for gastric cancer screening
Overall accuracy is defined as the percentage of all enrolled participants whose rbcDNA test result matches the final clinical-pathological gastric disease diagnosis. Final pathological diagnosis from standard hospital clinical examination serves as the gold-standard reference for calculation.
Time frame: Through study completion, an average of 1 year
Sensitivity of conventional gastric cancer screening tests
Percent of pathologically-confirmed gastric cancer participants with positive results from conventional screening assays, including serum tumor markers, Helicobacter pylori testing and pepsin-related indices. Calculated against final pathological gastric cancer diagnosis as unified gold standard.
Time frame: Through study completion, an average of 1 year
Specificity of conventional clinical gastric cancer screening tests
Percent of participants without pathologically-confirmed gastric cancer with negative results from conventional screening assays, including serum tumor markers, Helicobacter pylori testing and pepsin-related indices. Calculated against final pathological gastric cancer diagnosis as unified gold standard.
Time frame: Through study completion, an average of 1 year
Overall accuracy of conventional clinical gastric cancer screening tests
Proportion of all participants with consistent results from conventional screening assays relative to final pathological gastric cancer diagnosis (unified gold-standard reference). Conventional assays include serum tumor markers, Helicobacter pylori testing and pepsin-related indices.
Time frame: Through study completion, an average of 1 year
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