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

Hepatocellular Carcinoma Clinical Trial

Official title:

Refinement and Validation of a Comprehensive Clinical Diagnostic Model (GAMAD) for Early Detection of Hepatocellular Carcinoma: A Multicenter, Prospective Study Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05626985
• Other study ID #: GAMAD
• Status: Recruiting
• Start date: October 19, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Singlera Genomics Inc.
• Contact: Nanya Wang, Ph.D
• Phone: +8615804302611
• Email: wangny[@]jlu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Diagnostic Test:
• GAMAD
Blood samples are tested for tumor markers including PIVKA-II (DCP),AFP, ctDNA methylation and biochemical tests.

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Jilin
China	Eastern Hepatobiliary Surgery Hospital	Shanghai
China	Tianjin Third Central Hospital	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Singlera Genomics Inc.	The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

References & Publications (2)

Liu S, Sun L, Yao L, Zhu H, Diao Y, Wang M, Xing H, Lau WY, Guan M, Pawlik TM, Shen F, Xu M, Tong X, Yang T. Diagnostic Performance of AFP, AFP-L3, or PIVKA-II for Hepatitis C Virus-Associated Hepatocellular Carcinoma: A Multicenter Analysis. J Clin Med. 2022 Aug 29;11(17):5075. doi: 10.3390/jcm11175075. — View Citation

Yang T, Xing H, Wang G, Wang N, Liu M, Yan C, Li H, Wei L, Li S, Fan Z, Shi M, Chen W, Cai S, Pawlik TM, Soh A, Beshiri A, Lau WY, Wu M, Zheng Y, Shen F. A Novel Online Calculator Based on Serum Biomarkers to Detect Hepatocellular Carcinoma among Patients with Hepatitis B. Clin Chem. 2019 Dec;65(12):1543-1553. doi: 10.1373/clinchem.2019.308965. Epub 2019 Oct 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GAMAD	Using GAMAD calculator model to obtain the score of each group.	Day one
Secondary	GALAD	Using GALAD calculator to obtain the score of each group.	Day one
Secondary	circulating tumor DNA methylation	Using circulating tumor DNA methylation to obtain diagnostic value in pre-specified subgroups.	Day one