Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Observational
Started
2026-09-01
Last updated
2026-08-24
Condition(s) studied
Gastric Cancer
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Sensitivity of the rbcDNA blood test for gastric cancer screening — Through study completion, an average of 1 year 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.
Specificity of the rbcDNA blood test for gastric cancer screening — Through study completion, an average of 1 year 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.
Overall accuracy of the rbcDNA blood test for gastric cancer screening — Through study completion, an average of 1 year 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.
Trial sites (3)
Facility
City
Region
Status
Anyang Tumor Hospital
Anyang
Henan
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou
Zhejiang
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
China
More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.