Yliver as a Test to Early Diagnose HCC (YliverDIAG)

Corporacion Parc Tauli

Status

Completed

Conditions

Hepatocellular Carcinoma

Treatments

Diagnostic Test: Test Yliver

Study type

Observational

Funder types

Other

Identifiers

NCT03767764

CIR2017/024

Details and patient eligibility

About

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.

Enrollment

190 patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

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