Application Research of Artificial Intelligence-Assisted Novel Red Blood Cell DNA (rbcDNA) Detection for Early Diagnosis of Gastric Cancer
Sponsor study identifier
observational
542
1 country
3
Study Start
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 29, 2026
Actual (reported)August 24, 2026
Actual (reported)September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
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.
Through study completion, an average of 1 year
Sensitivity of conventional gastric cancer screening tests
Through study completion, an average of 1 year
Specificity of conventional clinical gastric cancer screening tests
Through study completion, an average of 1 year
Overall accuracy of conventional clinical gastric cancer screening tests
Through study completion, an average of 1 year
Subjects with histopathologically confirmed gastric cancer (stage I-IV)
Non-gastric cancer subjects, including superficial gastritis, gastric ulcer, adenomatous gastric polyps, atrophic gastritis, intestinal metaplasia, etc.
Participants consist of patients with gastric diseases undergoing gastroscopy, enrolled from three different medical centers across China.
Anyang Tumor Hospital
Anyang, Henan, 455000, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200001, China
Peripheral venous blood
Yuehua Han
Second Affiliated Hospital, Zhejiang University, School of Medicine
First Submitted
July 29, 2026
First Posted
August 24, 2026
Study Start
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2027
EstimatedBeta-Blockers on the Efficacy of Neoadjuvant Immunotherapy for Gastric Cancer
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 24, 2026
Record last verified: 2026-05
Individual participant data will not be shared publicly due to intellectual property protection of rbcDNA detection technology, restrictions from institutional ethics and informed consent of participants.
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Source: ClinicalTrials.gov.
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