Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
190 participants
OBSERVATIONAL
2018-12-27
2020-09-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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HCC
Patients with diagnosis of Hepatocellular carcinoma
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
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
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
Test Yliver
Test Yliver is used to detect autoantibodies against alpha fetoprotein in serum by an ELISA technique
Interventions
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Test Yliver
Test Yliver is used to detect autoantibodies against alpha fetoprotein in serum by an ELISA technique
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
99 Years
ALL
Yes
Sponsors
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Corporacion Parc Tauli
OTHER
Responsible Party
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Juan Francisco Delgado de la Poza
Senior Immunologist
Locations
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Corporacion Parc Taulí
Sabadell, Barcelona, Spain
Countries
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Other Identifiers
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CIR2017/024
Identifier Type: -
Identifier Source: org_study_id
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