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

Last updated: March 28, 2024
Sponsor: Singlera Genomics Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Disease

Liver Cancer

Liver Disorders

Treatment

GAMAD

Clinical Study ID

NCT05626985
GAMAD
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age above 18
  • Establishing Diagnosis according to the European Association for the Study ofLiver(EASL) criteria
  • High risk group of developing HCC including liver cirrhosis and hepatitis under theconfirmed 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

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 andother 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

Study Design

Total Participants: 2000
Treatment Group(s): 1
Primary Treatment: GAMAD
Phase:
Study Start date:
October 19, 2022
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • The First Hospital of Jilin University

    Jilin,
    China

    Active - Recruiting

  • Eastern Hepatobiliary Surgery Hospital

    Shanghai,
    China

    Active - Recruiting

  • Tianjin Third Central Hospital

    Tianjin,
    China

    Active - Recruiting

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