Primary Liver Cancer Early Detection

Liver Cancer Clinical Trial

— PRIMe-liver  

Official title:

Early Detection of Primary Liver Cancer Based on cfDNA Methylation: A Multi-Center Case-Control Study (PRIMe-liver)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05996666
• Other study ID #: RSCD2022015P
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: December 2023

Study information

• Verified date: August 2023
• Source: The First Hospital of Jilin University
• Contact: Bo Liu
• Phone: 18840110641
• Email: liuboliubo1109[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 701
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

• 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

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Device:
• Liver-cancer early detection test
Blood collection and liver-cancer early detection test

Locations

Country	Name	City	State
China	Jilin university first hospital	Changchun	Jilin
China	Eastern Hepatobiliary Surgery Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
The First Hospital of Jilin University	Guangzhou Burning Rock Dx Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of liver cancer early detection model based on selected cfDNA methylation markers using qPCR	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	2023.07.01-2023.12.30
Secondary	Performance of the liver cancer early detection model in detecting liver cancer at early stage	Sensitivity of the liver cancer early detection model in patients with small liver cancer lesions or AFP negative	2023.07.01-2023.12.30
Secondary	Performance of liver cancer early detection model in detecting liver cancer at different stages and subtypes	Sensitivity of the liver cancer early detection model in different stages or different pathological subtypes	2023.07.01-2023.12.30
Secondary	Performance of liver cancer early detection model to differentiate non-liver cancers	Specificity of the liver cancer early detection model to differentiate patients with benign liver diseases or different interfering cancer types from liver cancer	2023.07.01-2023.12.30
Secondary	Comparison of currently used biomarkers for liver cancer detection	Comparison of the sensitivity and specificity of the liver cancer early detection model and other biomarkers of liver cancer in detecting early liver cancer	2023.07.01-2023.12.30