Yliver as a Test to Early Diagnose HCC

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Diagnostic Test: Test Yliver

• Registration Number: NCT03767764
• Lead Sponsor: Corporacion Parc Tauli

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-05
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-07
• Study Start: 2018-12-27
• Primary Completion: 2020-04-01
• Study Completion: 2020-09-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HCC	Test Yliver	Patients with diagnosis of Hepatocellular carcinoma
Chronic liver diseases	Test Yliver	Patients with the diagnosis of Chronic liver diseases without cirrhosis
Cirrhosis	Test Yliver	Patients with the diagnosis of cirrhosis who is following a screening program for diagnosis of HCC
Control	Test Yliver	Normal human serum from donors without liver disease

Primary Outcome Measures

Name	Time	Method
Yliver	October 2018-February 2019	Titer of autoantibodies against alpha fetoprotein applying Taby Technology

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Corporacion Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain