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

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

NCT ID: NCT05626985

Condition: Hepatocellular Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular

Conditions: Keywords:
early detection

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: GAMAD
Description: Blood samples are tested for tumor markers including PIVKA-II (DCP),AFP, ctDNA methylation and biochemical tests.
Arm group label: Benign tumor-like lesions
Arm group label: Healthy control
Arm group label: Hepatitis
Arm group label: Hepatocellular Carcinoma patients
Arm group label: Liver cirrhosis

Summary: 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.

Detailed 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.

Criteria for eligibility:

Study pop:
Patients must have baseline evaluations performed prior to the study and must meet all inclusion and exclusion criteria. In addition, the patient must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent. The written informed consent must be obtained from the patient prior to enrollment. The following criteria apply to all patients enrolled onto the study unless otherwise specified

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: The First Hospital of Jilin University

Address:
City: Jilin
Country: China

Status: Recruiting

Contact:
Last name: Nanya Wang, Ph.D

Facility:
Name: Eastern Hepatobiliary Surgery Hospital

Address:
City: Shanghai
Country: China

Status: Recruiting

Contact:
Last name: Tian Yang, PHD

Facility:
Name: Tianjin Third Central Hospital

Address:
City: Tianjin
Country: China

Status: Recruiting

Contact:
Last name: Fengmei Wang, PHD

Start date: October 19, 2022

Completion date: December 2024

Lead sponsor:
Agency: Singlera Genomics Inc.
Agency class: Industry

Collaborator:
Agency: The First Hospital of Jilin University
Agency class: Other

Source: Singlera Genomics Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05626985