Yliver as a Test to Early Diagnose HCC

Yliver as a Test to Early Diagnose Hepatocellular Carcinoma

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03767764

Acronym

YliverDIAG

Enrollment

190

Registered

2018-12-07

Start date

2018-12-27

Completion date

2020-09-01

Last updated

2021-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma, Tumor associated antigen, Early diagnosis, Autoantibodies, Alpha fetoprotein

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.

Interventions

DIAGNOSTIC_TESTTest Yliver

Test Yliver is used to detect autoantibodies against alpha fetoprotein in serum by an ELISA technique

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026