AI-Assisted Novel rbcDNA Detection for Early Gastric Cancer Diagnosis

Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Study ID
NCT07782294
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Aug 24, 2026
Start date
Sep 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
542 participants (estimated)

Arms

  • Arm: GC group
    Subjects with histopathologically confirmed gastric cancer (stage I-IV)
  • Arm: Contol group
    Non-gastric cancer subjects, including superficial gastritis, gastric ulcer, adenomatous gastric polyps, atrophic gastritis, intestinal metaplasia, etc.

Primary Outcome Measure

Sensitivity of the rbcDNA blood test for gastric cancer screening [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

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