Detection Evaluation of a Novel Blood-based DNA Methylation Assay in Early-stage Hepatocellular Carcinoma Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 4,816
- 试验地点
- 9
- 主要终点
- All plasma samples and imaging results will be used to evaluate diagnostic(sensitivity and specificity) of the kit.
研究概览
简要总结
This trail is a multi-center,prospective observational study aimed to detect early-stage Hepatocellular Carcinoma by a Novel Blood-based DNA Methylation Assay(named Genetron HCC Methylation PCR Kit ). The accuracy of the kit will also be evaluated . The trail will be enroll approximately 4816 participants, including participants with HCC or benign diseases, and high risk factors for liver cancer.
详细描述
Diagnostic performance evaluation:
Alpha-fetoprotein (AFP), liver ultrasound (US), dynamic contrast enhanced MRI and the kit examination will be performed on high-risk participants of primary liver cancer.
For subjects with typical imaging findings of hepatocellular carcinoma but an intrahepatic nodule diameter of ≤2 cm, an imaging study will be added to the above.
According to the clinical diagnostic criteria of primary liver cancer, the diagnostic performance of the kit, liver ultrasound examination (US) combined with alpha fetoprotein (AFP) detection will be evaluated, and the sensitivity of the kit, the kit combined with AFP, the kit combined with AFP and US, AFP combined with US screening for primary liver cancer will be compared.
Test performance evaluation:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 接受健康志愿者
- 否
入选标准
- •Have high risk factors for liver cancer such as HBV and/or HCV infection, alcoholic liver disease, non-alcoholic steatohepatitis, long-term consumption of food contaminated with aflatoxin, liver cirrhosis caused by various other reasons, and family history of liver cancer Wait;
- •I or my legal representative can read, understand and sign the informed consent;
- •Agree to provide blood samples, be able to receive imaging examinations and have good clinical compliance;
- •The complete clinical basic information includes: the patient's unique traceability number (ID number/outpatient clinic number/medical insurance card number), age, gender, etc.
排除标准
- •pregnant women;
- •Have received an organ transplant;
- •Diagnosed with other tumors;
- •The investigators judged that they were not eligible for inclusion.
- •Test performance evaluation:
- •Inclusion Criteria:
- •Confirmed primary hepatocellular carcinoma or confirmed non-HCC;
- •I or my legal representative can read, understand and sign the informed consent;
- •Agree to provide blood samples and have good clinical compliance;
- •The basic clinical information is complete, including: the patient's unique traceability number (ID number/outpatient clinic number/medical insurance card number), age, gender, imaging and/or pathological diagnosis results (for patients with primary liver cancer), imaging examination confirmed non-identical Liver cancer (non-HCC patients).
- •Exclusion Criteria:
- •pregnant women;
- •Have received an organ transplant;
- •Non-HCC patients diagnosed with other tumors;
- •Patients with primary hepatocellular carcinoma combined with other tumors;
- •The investigator judges that they are not eligible for inclusion.
结局指标
主要结局
All plasma samples and imaging results will be used to evaluate diagnostic(sensitivity and specificity) of the kit.
时间窗: 2 months
Alpha-fetoprotein (AFP), liver ultrasound (US), dynamic contrast enhanced MRI and the kit examination will be performed on high-risk participants of primary liver cancer. For subjects with typical imaging findings of hepatocellular carcinoma but an intrahepatic nodule diameter of ≤2 cm, an imaging study will be added to the above. According to the clinical diagnostic criteria of primary liver cancer, the diagnostic performance of the kit, liver ultrasound examination (US) combined with alpha fetoprotein (AFP) detection will be evaluated, and the sensitivity of the kit, the kit combined with AFP, the kit combined with AFP and US, AFP combined with US screening for primary liver cancer will be compared.
Plasma samples of patients with and without HCC to evaluate test performance(accuracy) of the kit. diagnostic(sensitivity and specificity) of the kit.
时间窗: 2 months
Following the principle of simultaneous blinding, blood samples were collected from liver cancer patients and non-HCC patients who had been diagnosed according to the clinical diagnostic criteria for primary liver cancer. The subjects were coded, and the selected samples were tested by the kit and the comparison method high-throughput human methylation sequencing (NGS sequencing method), and the test results were compared.
次要结局
未报告次要终点