A Multicenter Clinical Trial to Evaluate the Clinical Performance and Accuracy of the Human DAB2IP, CHFR, and GRASP Gene Methylation Kit (PCR-fluorescence Probe) in Patients With Suspected Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Study on the clinical performance of human DAB2IP, CHFR and GRASP gene methylation detection kit (PCR-fluorescent probe method)
研究概览
简要总结
This clinical trial aims to systematically evaluate the clinical performance and accuracy of the HepaAiQ test kit, a multi-gene methylation assay based on PCR with fluorescent probe detection. The test results are compared against clinical reference standards, including pathological and/or imaging diagnoses, to assess the product's diagnostic performance. Additionally, for each gene detectable by the HepaAiQ assay, digital PCR is used as a comparator to validate analytical accuracy. The dual approach-clinical and analytical validation-supports the intended use of the test and provides sufficient clinical evidence for its registration and regulatory submission in China.
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 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older, gender unlimited;
- •Subjects for whom sufficient blood samples can be obtained (whole blood volume not less than 10 mL);
- •The performance of the blood-based, multi-gene methylation test is being evaluated in a diverse population including:
- •(i) Treatment-naïve individuals presenting with signs and/or symptoms suggestive of hepatocellular carcinoma (HCC) as assessed by clinicians; (ii) Individuals at high risk for liver cancer, including those with HBV or HCV infection, excessive alcohol intake, non-alcoholic steatohepatitis (NASH), liver cirrhosis of various etiologies (LC), benign hepatic lesions (BHL), or a family history of liver cancer; (iii) Patients with other malignancies, including but not limited to esophageal, gastric, colorectal, pancreatic, lung, breast, and prostate cancers.
- •Voluntarily participate in the experiment and sign the informed consent.
排除标准
- •Liver cancer subjects who have received previous treatment, such as radiotherapy and chemotherapy, surgery, etc.;
- •Subjects with other malignant tumors;
- •Subjects with recurrent liver cancer confirmed or suspected by the investigator;
- •Subjects whose information is missing or untraceable;
- •The researcher believes that the subjects should not be included in this study for other reasons.
结局指标
主要结局
Study on the clinical performance of human DAB2IP, CHFR and GRASP gene methylation detection kit (PCR-fluorescent probe method)
时间窗: From enrollment to the end of detection at 16 week
By comparing the test reagent with the clinical reference standard (pathological diagnosis and/or imaging diagnosis), the test results of the test reagent were compared with the clinical reference standard to verify the clinical performance of the product
次要结局
- Accuracy of human DAB2IP, CHFR and GRASP gene methylation detection kit (PCR-fluorescent probe method)(From enrollment to the end of detection at 16 week)