Yliver as a Test to Early Diagnose HCC

Hepatocellular Carcinoma Clinical Trial

— YliverDIAG  

Official title:

Yliver as a Test to Early Diagnose Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03767764
• Other study ID #: CIR2017/024
• Status: Completed
• Start date: December 27, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: July 2021
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: September 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
Spain	Corporacion Parc Taulí	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yliver	Titer of autoantibodies against alpha fetoprotein applying Taby Technology	October 2018-February 2019
Secondary	AFP	Levels of alpha fetoprotein in serum	October 2018-February 2019
Secondary	Ultrasound	Results of the ultrasound examination	October 2018-February 2019
Secondary	AAb AFP	Titer of autoantibodies against alpha fetoprotein with standard protocol	October 2018-February 2019