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OpenTrials
Completed

NCT Number: NCT03767764

Yliver as a Test to Early Diagnose HCC

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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Corporacion Parc Taulí

Sabadell, Barcelona, 08208, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test Yliver

Diagnostic Test

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

Primary outcomes

  1. Yliver

    Time frame: October 2018-February 2019

    Titer of autoantibodies against alpha fetoprotein applying Taby Technology

Secondary outcomes

  1. AFP

    Time frame: October 2018-February 2019

    Levels of alpha fetoprotein in serum

  2. Ultrasound

    Time frame: October 2018-February 2019

    Results of the ultrasound examination

  3. AAb AFP

    Time frame: October 2018-February 2019

    Titer of autoantibodies against alpha fetoprotein with standard protocol

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

Yliver as a Test to Early Diagnose Hepatocellular Carcinoma

Acronym: YliverDIAG

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 7, 2018
Registry last updated
Jul 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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