Yliver as a Test to Early Diagnose Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Yliver
研究概览
简要总结
Liver cancer (HCC) is the second cause of death related to cancer worldwide, with about 750,000 deaths from this cause in 2012. Although the early diagnosis of liver cancer increases the available treatment options, the methods currently used for screening are not sufficiently sensitive for this purpose.
The investigators provide a high-performance and highly reliable in vitro platform that allows the identification and quantification of autoantibodies in serum for use as biomarkers of liver cancer, using an ELISA test (Yliver).
The aim of the study is to demonstrate whether the Yliver test can be used as a biomarker for the early diagnosis of hepatocellular carcinoma with a collection of samples from 58 patients diagnosed with HCC, 42 cirrhosis, 40 normal controls and the inclusion of 25-50 patients with chronic liver disease without cirrhosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •EASL Clinical Practice Guidelines & Practice Guidance by the American Association for the Study of Liver Diseases for diagnosis of HCC, liver cirrhosis, chronic hepatitis without cirrhosis
排除标准
- •Age under 18 years
- •Very advanced disease (patient in a terminal state that is not indicated analytical determinations).
- •Hepatic encephalopathy that prevents the correct understanding of informed consent.
- •Refusal to carry out the determination or to sign the informed consent.
- •Patients affected by another neoplastic disease
结局指标
主要结局
Yliver
时间窗: October 2018-February 2019
Titer of autoantibodies against alpha fetoprotein applying Taby Technology
次要结局
- Ultrasound(October 2018-February 2019)
- AFP(October 2018-February 2019)
- AAb AFP(October 2018-February 2019)
研究者
Juan Francisco Delgado de la Poza
Senior Immunologist
Corporacion Parc Tauli