Refinement and Validation of a Comprehensive Clinical Diagnostic Model (GAMAD) for Early Detection of Hepatocellular Carcinoma: A Multicenter, Prospective Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 3
- 主要终点
- GAMAD
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
GAMAD
时间窗: Day one
Using GAMAD calculator model to obtain the score of each group.
次要结局
- GALAD(Day one)
- circulating tumor DNA methylation(Day one)