NCT05996666招募中不适用
Early Detection of Primary Liver Cancer Based on cfDNA Methylation: A Multi-Center Case-Control Study (PRIMe-liver)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 701
- 试验地点
- 2
- 主要终点
- Performance of liver cancer early detection model based on selected cfDNA methylation markers using qPCR
研究概览
简要总结
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.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Exclusion Criteria for All the Participants:
- •Individuals cannot provide blood samples at the study-specified blood collection sites
- •Pregnancy or lactating women
- •Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
- •Recipients of blood transfusion within 7 days prior to blood sample collection
- •Recipients of anti-infective treatment within 14 days prior to blood sample collection
- •Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer
- •Individuals with a history of malignant tumor
- •Exclusion Criteria for liver cancer participants:
- •Known prior or current diagnosis of other types of malignancies or multiple primary cancers
- •No confirmed diagnosis of liver cancer after blood sample collection
- •Exclusion Criteria for participants with benign liver diseases:
- •Individuals with a confirmed diagnosis of a malignant tumor or precancerous lesion
- •Individuals who cannot be diagnosed as having benign liver diseases after blood sample collection
- •Exclusion Criteria for participants with interfering cancers:
- •Known prior or current diagnosis of other types of malignancies or multiple primary cancers
- •No confirmed diagnosis of any type of interfering cancers after blood sample collection
- •Exclusion Criteria for healthy participants:
- •Prior or ongoing treatment of cancers within 3 years prior to blood sample collection
- •Clinically significant or uncontrolled comorbidities
结局指标
主要结局
Performance of liver cancer early detection model based on selected cfDNA methylation markers using qPCR
时间窗: 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
次要结局
- Comparison of currently used biomarkers for liver cancer detection(2023.07.01-2023.12.30)
- Performance of the liver cancer early detection model in detecting liver cancer at early stage(2023.07.01-2023.12.30)
- Performance of liver cancer early detection model in detecting liver cancer at different stages and subtypes(2023.07.01-2023.12.30)
- Performance of liver cancer early detection model to differentiate non-liver cancers(2023.07.01-2023.12.30)
研究者
Guoyue Lv
Professor of Gastroenterology & Hepatology
The First Hospital of Jilin University
研究点 (2)
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