AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Hepatobiliary Cancer Malignancies

Development and Validation of the Performance of a cfDNA Methylation-based Model Combined With Serum Tumor Markers for Early Hepatobiliary Malignancies Detection

This study is a prospective, multicenter study aimed to develop and validate the performance of combined assays for cfDNA methylation markers and serum tumor markers in early hepatobiliary malignancies detection. Circulating tumor DNA (ctDNA) mutation, blood RNA markers and tissue will also be evaluated. The study will enroll approximately 496 participants, including participants with malignant or benign diseases of the hepatobiliary system.

Inclusion Criteria for All the Participants:

• 40-75 years old
• Ability to comply with study procedures
• Ability to provide a written informed consent

Exclusion Criteria for All the Participants:

• 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 study blood draw
• Recipients of anti-microbial therapy within 14 days prior to study blood draw
• Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer

Inclusion Criteria for Cancer Arm Participants:

• Confirmed diagnosis or highly suspicious cases of hepatobiliary malignancies
• No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw

Exclusion Criteria for Cancer Arm Participants:

• Current diagnosis of other malignancies or multiple primary tumors
• Diagnosis of benign diseases by histopathological assessments
• Inability to characterize whether the lesion is malignant or benign
• Prior or ongoing treatment of cancer

Inclusion Criteria for Benign Diseases Arm Participants:

• Confirmed diagnosis of benign diseases of the hepatobiliary system
• No prior radical treatment of the benign diseases prior to study blood draw

Exclusion Criteria for Benign Diseases Arm Participants:

• Current or history of malignancies or precancerous lesions
• No confirmed diagnosis or inability to characterize a benign disease