Yliver as a Test to Early Diagnose Hepatocellular Carcinoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Corporacion Parc Tauli
- Enrollment
- 190
- Locations
- 1
- Primary Endpoint
- Yliver
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Juan Francisco Delgado de la Poza
Senior Immunologist
Corporacion Parc Tauli
Eligibility Criteria
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
Outcomes
Primary Outcomes
Yliver
Time Frame: October 2018-February 2019
Titer of autoantibodies against alpha fetoprotein applying Taby Technology
Secondary Outcomes
- Ultrasound(October 2018-February 2019)
- AFP(October 2018-February 2019)
- AAb AFP(October 2018-February 2019)