Yliver as a Test to Early Diagnose HCC

Study Overview
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Brief Summary
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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.

Official Title
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Yliver as a Test to Early Diagnose Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Diagnostic Test: Test Yliver


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HCC<br>Patients with diagnosis of Hepatocellular carcinoma | Diagnostic Test: Test Yliver<br>* Test Yliver is used to detect autoantibodies against alpha fetoprotein in serum by an ELISA technique<br>|
| Cirrhosis<br>Patients with the diagnosis of cirrhosis who is following a screening program for diagnosis of HCC | Diagnostic Test: Test Yliver<br>* Test Yliver is used to detect autoantibodies against alpha fetoprotein in serum by an ELISA technique<br>|
| Chronic liver diseases<br>Patients with the diagnosis of Chronic liver diseases without cirrhosis | Diagnostic Test: Test Yliver<br>* Test Yliver is used to detect autoantibodies against alpha fetoprotein in serum by an ELISA technique<br>|
| Control<br>Normal human serum from donors without liver disease | Diagnostic Test: Test Yliver<br>* Test Yliver is used to detect autoantibodies against alpha fetoprotein in serum by an ELISA technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yliver | Titer of autoantibodies against alpha fetoprotein applying Taby Technology | October 2018-February 2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AFP | Levels of alpha fetoprotein in serum | October 2018-February 2019 | 
| Ultrasound | Results of the ultrasound examination | October 2018-February 2019 | 
| AAb AFP | Titer of autoantibodies against alpha fetoprotein with standard protocol | October 2018-February 2019 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular carcinoma, Tumor associated antigen, Early diagnosis, Autoantibodies, Alpha fetoprotein