Refinement and Validation of a Diagnostic Model (GAMAD) for Early Detection of Hepatocellular Carcinoma

Singlera Genomics

Status: Enrolling

Conditions: Hepatocellular Carcinoma

Treatments: Diagnostic Test: GAMAD

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05626985

GAMAD

Details and patient eligibility

About

Most hepatocellular carcinoma (HCC) cases were at advanced stage when diagnosis established. This study is intended to establish a clinical diagnostic model GAMAD for early-stage HCC and evaluate the diagnostic efficiency the same time. This study is a multicenter prospective study. Participants including healthy control,HCC, liver cirrhosis, hepatitis and benign tumor-like lesions are consecutively recruited into the cohort. All the blood samples are collected before any treatments and will be tested in single center in order to decrease bias.

Full description

GALAD score including age, sex, PIVKA-II(DCP), Alpha-fetoprotein (AFP) and alpha-fetoprotein L3 (AFP-L3), is a serum biomarker-based panel that can aid in early detection among patients with a high risk for liver cancer. While increasing studies showed the diagnostic accuracy of AFP-L3 was not as good as that of AFP or PIVKA-II, and AFP-L3 was not significant in the multivariable model. Thus, a model with better diagnostic accuracy and more suitable for Chinese patients is needed. Here, based on a multi-locus blood-based assay targeting circulating tumor DNA methylation, we aim to develop a novel diagnostic model--GAMAD (gender, age, methylation, AFP and DCP) and validate its performance among HCC patients and those at high risk of developing HCC,such as liver cirrhosis, hepatitis patients. This is a multicenter, observational, prospective study. After giving fully informed consent, the participants will undergo the regular treatment according to NCCN guidelines.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age above 18
• Establishing Diagnosis according to the European Association for the Study of Liver(EASL) criteria
• High risk group of developing HCC including liver cirrhosis and hepatitis under the confirmed diagnosis
• Able to provide sufficient and qualified blood samples for study tests
• No prior or undergoing cancer treatment (local or systematic)
• Able to provide a written informed consent

Exclusion criteria

• Obstructive jaundice patients
• Medical history of taking warfarin
• With other known malignant tumors or multiple primary tumors
• Patients with autoimmune diseases, genetic diseases, mental diseases/ disabilities and other diseases considered unsuitable for the study by the investigator
• During pregnancy or lactation
• Recipient of blood transfusion within 3 months prior to study blood draw
• Insufficient qualified blood sample for study test

Trial design

2,000 participants in 5 patient groups

Hepatocellular Carcinoma patients

Description:

Blood samples are collected before liver resection.

Treatment:

Diagnostic Test: GAMAD

Liver cirrhosis

Description:

The diagnosis of liver cirrhosis are based on triple-phase contrast enhanced computed tomography, magnetic resonance imaging.

Treatment:

Diagnostic Test: GAMAD

Hepatitis

Description:

Patients with various hapatitis.

Treatment:

Diagnostic Test: GAMAD

Benign tumor-like lesions

Description:

Benign hepatic tumors were diagnosed based on imaging findings and histological examinations after hepatic resection.

Treatment:

Diagnostic Test: GAMAD

Healthy control

Description:

The healthy control group consist of people undergoing routine medical examination. Blood samples are collected.

Treatment:

Diagnostic Test: GAMAD