Application Research of Artificial Intelligence-Assisted Novel Red Blood Cell DNA (rbcDNA) Detection for Early Diagnosis of Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 542
- 试验地点
- 3
- 主要终点
- Sensitivity of the rbcDNA blood test for gastric cancer screening
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Sensitivity of the rbcDNA blood test for gastric cancer screening
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)