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AI-Assisted Novel rbcDNA Detection for Early Gastric Cancer Diagnosis

NCT07782294 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 542

Last updated 2026-08-24

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Anyang Tumor Hospital

    collaborator OTHER

  • RenJi Hospital

    collaborator OTHER

  • Second Affiliated Hospital, Zhejiang University, School of Medicine

    lead OTHER

Principal Investigators

  • Yuehua Han · Second Affiliated Hospital, Zhejiang University, School of Medicine

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07782294 on ClinicalTrials.gov