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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Hepatobiliary Malignancies

Intervention / Treatment
-----------------
* Device: Multi-cancer early detection test


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer Arm<br>Participants with new diagnosis of hepatobiliary malignancies, from whom blood samples will be collected | Device: Multi-cancer early detection test<br>* Blood collection and multi-cancer early detection testing<br>|
| Benign Diseases Arm<br>Participants with benign diseases of the hepatobiliary system, from whom blood samples will be collected | Device: Multi-cancer early detection test<br>* Blood collection and multi-cancer early detection testing<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of early hepatobiliary malignancies detection and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model combined with serum tumor markers when specificity was 90%, 95% or 98% |  | 16 months | 
| Sensitivity and specificity of early hepatobiliary malignancies detection and TOO accuracy of a cfDNA methylation-based model combined with serum tumor markers |  | 16 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in early detection of hepatobiliary malignancies in different stages |  | 16 months | 
| Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers, clinical characteristics and other biomarkers |  | 16 months | 
| Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in participants with malignant or benign diseases of the hepatobiliary system |  | 16 months | 
| Sensitivity and specificity of a cfDNA methylation-based model or serum tumor markers in participants with hepatobiliary malignancies |  | 16 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatobiliary malignancies, Liquid biopsy, Cell-free DNA, Early detection