Yliver as a Test to Early Diagnose HCC

NCT03767764 | Completed DMC

• 1 other identifier: CIR2017/024
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Yliver

  Titer of autoantibodies against alpha fetoprotein applying Taby Technology

  October 2018-February 2019

Secondary Outcomes (3)

• AFP

  October 2018-February 2019

• Ultrasound

  October 2018-February 2019

• AAb AFP

  October 2018-February 2019

Study Arms (4)

HCC

Patients with diagnosis of Hepatocellular carcinoma

Diagnostic Test: Test Yliver

Cirrhosis

Patients with the diagnosis of cirrhosis who is following a screening program for diagnosis of HCC

Diagnostic Test: Test Yliver

Chronic liver diseases

Patients with the diagnosis of Chronic liver diseases without cirrhosis

Diagnostic Test: Test Yliver

Control

Normal human serum from donors without liver disease

Diagnostic Test: Test Yliver

Interventions

Test Yliver DIAGNOSTIC_TEST

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

Chronic liver diseases; Cirrhosis; Control; HCC

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Corporacion Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Disease

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Immunologist

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 7, 2018
• Study Start: December 27, 2018
• Primary Completion: April 1, 2020
• Study Completion: September 1, 2020
• Last Updated: July 29, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)