PRIMe-liver: Primary Liver Cancer Early Detection
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Liver cancer arm Participants with new diagnosis of liver cancer, from whom blood samples will be collected. |
Device: Liver-cancer early detection test
Blood collection and liver-cancer early detection test
|
| Benign diseases arm Participants with benign diseases of cancer, from whom blood samples will be collected. |
Device: Liver-cancer early detection test
Blood collection and liver-cancer early detection test
|
| Healthy arm Participants without known presence of malignancies or benign diseases of liver, from whom blood samples will be collected. |
Device: Liver-cancer early detection test
Blood collection and liver-cancer early detection test
|
| Interfering cancer arm Participants with new diagnosis of interfering cancer types, from whom blood samples will be collected. |
Device: Liver-cancer early detection test
Blood collection and liver-cancer early detection test
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
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
Exclusion Criteria:
Exclusion Criteria for All the Participants:
-
Individuals cannot provide blood samples at the study-specified blood collection sites
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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
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Recipients of anti-infective treatment within 14 days prior to blood sample collection
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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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jilin university first hospital | Changchun | Jilin | China | |
| 2 | Eastern Hepatobiliary Surgery Hospital | Shanghai | Shanghai | China |
Sponsors and Collaborators
- The First Hospital of Jilin University
- Guangzhou Burning Rock Dx Co., Ltd.
Investigators
- Principal Investigator: Tian Yang, Eastern Hepatobiliary Surgery Hospital
- Principal Investigator: Nanya Wang, The First Hospital of Jilin University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RSCD2022015P