Yliver as a Test to Early Diagnose HCC (YliverDIAG)

Yliver as a Test to Early Diagnose Hepatocellular Carcinoma

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.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Diagnostic test: Test Yliver

• Study Type: Observational
• Enrollment (Actual): 190

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Corporacion Parc Tauli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

HCC: patients with HCC diagnosis Cirrhosis: patients with liver cirrhosis diagnosis Chronic liver disease: patients with chronic liver diasease without cirrhosis Control: normal human serum from donors without liver disease

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2018
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 6, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Hepatocellular carcinoma; Autoantibodies; Early diagnosis; Alpha fetoprotein; Tumor associated antigen
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: CIR2017/024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No