Gastric Cancer
Conditions
Keywords
Gastric cancer, rbcDNA, Early detection
Brief 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.
Interventions
None listed
Sponsors
Second Affiliated Hospital, Zhejiang University, School of Medicine
Anyang Tumor Hospital
RenJi Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of conventional gastric cancer screening tests | Through study completion, an average of 1 year | 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. |
| Specificity of conventional clinical gastric cancer screening tests | Through study completion, an average of 1 year | 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. |
| Overall accuracy of conventional clinical gastric cancer screening tests | Through study completion, an average of 1 year | 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. |
Countries
China
Contacts
CONTACTYuehua Han
STUDY_CHAIRYuehua Han
Second Affiliated Hospital, Zhejiang University, School of Medicine
Outcome results
None listed