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| Name | Class |
|---|---|
| Third Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Guangzhou eighth People's Hospital ,Guangzhou Medilcal University | UNKNOWN |
| The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China |
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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.
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:
Plasma samples of patients with and without HCC diagnosed according to the clinical diagnostic criteria of primary HCC will be collected and examined simultaneously by the kit and high-throughput human methylation sequencing (NGS sequencing).
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| Measure | Description | Time Frame |
|---|---|---|
| All plasma samples and imaging results will be used to evaluate diagnostic(sensitivity and specificity) of the kit. | 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. | 2 months |
| Plasma samples of patients with and without HCC to evaluate test performance(accuracy) of the kit. diagnostic(sensitivity and specificity) of the kit. | 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. | 2 months |
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Diagnostic performance evaluation:
Inclusion Criteria:
Exclusion Criteria:
Test performance evaluation:
Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with primary hepatocellular carcinoma, or with 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, various other causes of liver cirrhosis, and patients with a family history of liver cancer, etc.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Youan Hospital,Capital Medical University Beijing Institute of Hepatology | Beijing | China | ||||
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 5, 2022 | May 6, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| West China Hospital | OTHER |
| Beijing Youan Hospital,Capital Medical University Beijing Institute of Hepatology | UNKNOWN |
| Ruijin Hospital | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Wuxi No.5 People's Hospital | UNKNOWN |
| Peking University First Hospital | OTHER |
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| Xiangya Hospital of Central South University |
| Changsha |
| China |
| West China School of Medicine/West China Hospital of Sichuan University | Chengdu | China |
| Guangzhou eighth People's Hospital ,Guangzhou Medilcal University | Guangzhou | China |
| The Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | China |
| Nantong Tumor Hospital | Nantong | China |
| Ruijin Hospital, Shanghai Jiaotong University School | Shanghai | China |
| Wuxi No.5 People's Hospital | Wuxi | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | China |
| D008107 |
| Liver Diseases |