Liver Cancer
Conditions
Keywords
Early detection, Liver cancer, cell-free DNA (cfDNA), qPCR
Brief summary
In the recently published multi-center, prospective, single-blind study (THUNDER study), using the methylation signal in cfDNA isolated from the peripheral blood to detect the six types of cancer, the sensitivity for liver cancer detection achieved 87.8%, with a specificity of 98.9%. In this study, a multicenter, case-control study is designed to establish an early cancer detection model based on cfDNA methylation biomarkers using qPCR to detect primary liver cancer and further validate the performance of the model.
Interventions
DEVICELiver-cancer early detection test
Blood collection and liver-cancer early detection test
Sponsors
Guangzhou Burning Rock Dx Co., Ltd.
The First Hospital of Jilin University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria for all participants * Individuals aged 18-74 years old * Individuals capable of giving signed and legally effective informed consent voluntarily Inclusion Criteria for liver cancer participants: * Individuals newly diagnosed with or suspected of having liver cancer (including hepatocellular carcinoma \[HCC\], intrahepatic cholangiocarcinoma \[ICC\], and combined hepatocellular-cholangiocarcinoma \[cHCC-CCA\]). * Individuals without any anti-cancer therapy prior to blood sample collection. Inclusion Criteria for participants with benign liver diseases: * Individuals newly diagnosed as benign liver diseases before blood sample collection * Individuals without curative treatment for the disease before blood sample collection Inclusion Criteria for participants with interfering cancers: * Individuals diagnosed with or suspected of having interfering cancer * Individuals without any anti-cancer therapy prior to blood sample collection Inclusion Criteria for healthy participants: * No cancer-related or other clinical symptoms 30 days prior to blood sample collection * No prior history of benign liver diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of liver cancer early detection model based on selected cfDNA methylation markers using qPCR | 2023.07.01-2023.12.30 | Sensitivity and specificity of liver cancer detection model based on selected cfDNA methylation biomarkers using qPCR in subjects with primary liver cancer or benign liver diseases, interfering cancers and healthy individuals |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance of the liver cancer early detection model in detecting liver cancer at early stage | 2023.07.01-2023.12.30 | Sensitivity of the liver cancer early detection model in patients with small liver cancer lesions or AFP negative |
| Performance of liver cancer early detection model in detecting liver cancer at different stages and subtypes | 2023.07.01-2023.12.30 | Sensitivity of the liver cancer early detection model in different stages or different pathological subtypes |
| Performance of liver cancer early detection model to differentiate non-liver cancers | 2023.07.01-2023.12.30 | Specificity of the liver cancer early detection model to differentiate patients with benign liver diseases or different interfering cancer types from liver cancer |
| Comparison of currently used biomarkers for liver cancer detection | 2023.07.01-2023.12.30 | Comparison of the sensitivity and specificity of the liver cancer early detection model and other biomarkers of liver cancer in detecting early liver cancer |
Countries
China
Contacts
Primary ContactBo Liu
Backup ContactShangli Cai
Outcome results
None listed