<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03767764</url>
  </required_header>
  <id_info>
    <org_study_id>CIR2017/024</org_study_id>
    <nct_id>NCT03767764</nct_id>
  </id_info>
  <brief_title>Yliver as a Test to Early Diagnose HCC</brief_title>
  <acronym>YliverDIAG</acronym>
  <official_title>Yliver as a Test to Early Diagnose Hepatocellular Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corporacion Parc Tauli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corporacion Parc Tauli</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Liver cancer (HCC) is the second cause of death related to cancer worldwide, with about&#xD;
      750,000 deaths from this cause in 2012. Although the early diagnosis of liver cancer&#xD;
      increases the available treatment options, the methods currently used for screening are not&#xD;
      sufficiently sensitive for this purpose.&#xD;
&#xD;
      The investigators provide a high-performance and highly reliable in vitro platform that&#xD;
      allows the identification and quantification of autoantibodies in serum for use as biomarkers&#xD;
      of liver cancer, using an ELISA test (Yliver).&#xD;
&#xD;
      The aim of the study is to demonstrate whether the Yliver test can be used as a biomarker for&#xD;
      the early diagnosis of hepatocellular carcinoma with a collection of samples from 58 patients&#xD;
      diagnosed with HCC, 42 cirrhosis, 40 normal controls and the inclusion of 25-50 patients with&#xD;
      chronic liver disease without cirrhosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 27, 2018</start_date>
  <completion_date type="Actual">September 1, 2020</completion_date>
  <primary_completion_date type="Actual">April 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Yliver</measure>
    <time_frame>October 2018-February 2019</time_frame>
    <description>Titer of autoantibodies against alpha fetoprotein applying Taby Technology</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AFP</measure>
    <time_frame>October 2018-February 2019</time_frame>
    <description>Levels of alpha fetoprotein in serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ultrasound</measure>
    <time_frame>October 2018-February 2019</time_frame>
    <description>Results of the ultrasound examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AAb AFP</measure>
    <time_frame>October 2018-February 2019</time_frame>
    <description>Titer of autoantibodies against alpha fetoprotein with standard protocol</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">190</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>HCC</arm_group_label>
    <description>Patients with diagnosis of Hepatocellular carcinoma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cirrhosis</arm_group_label>
    <description>Patients with the diagnosis of cirrhosis who is following a screening program for diagnosis of HCC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic liver diseases</arm_group_label>
    <description>Patients with the diagnosis of Chronic liver diseases without cirrhosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Normal human serum from donors without liver disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Test Yliver</intervention_name>
    <description>Test Yliver is used to detect autoantibodies against alpha fetoprotein in serum by an ELISA technique</description>
    <arm_group_label>Chronic liver diseases</arm_group_label>
    <arm_group_label>Cirrhosis</arm_group_label>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>HCC</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        HCC: patients with HCC diagnosis Cirrhosis: patients with liver cirrhosis diagnosis Chronic&#xD;
        liver disease: patients with chronic liver diasease without cirrhosis Control: normal human&#xD;
        serum from donors without liver disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        EASL Clinical Practice Guidelines &amp; Practice Guidance by the American Association for the&#xD;
        Study of Liver Diseases for diagnosis of HCC, liver cirrhosis, chronic hepatitis without&#xD;
        cirrhosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age under 18 years&#xD;
&#xD;
          -  Very advanced disease (patient in a terminal state that is not indicated analytical&#xD;
             determinations).&#xD;
&#xD;
          -  Hepatic encephalopathy that prevents the correct understanding of informed consent.&#xD;
&#xD;
          -  Refusal to carry out the determination or to sign the informed consent.&#xD;
&#xD;
          -  Patients affected by another neoplastic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Corporacion Parc Taulí</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>July 28, 2021</last_update_submitted>
  <last_update_submitted_qc>July 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Corporacion Parc Tauli</investigator_affiliation>
    <investigator_full_name>Juan Francisco Delgado de la Poza</investigator_full_name>
    <investigator_title>Senior Immunologist</investigator_title>
  </responsible_party>
  <keyword>Hepatocellular carcinoma</keyword>
  <keyword>Tumor associated antigen</keyword>
  <keyword>Early diagnosis</keyword>
  <keyword>Autoantibodies</keyword>
  <keyword>Alpha fetoprotein</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03767764
org study id: CIR2017/024
nct id: NCT03767764
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Yliver
time frame: October 2018-February 2019
description: Titer of autoantibodies against alpha fetoprotein applying Taby Technology
measure: AFP
time frame: October 2018-February 2019
description: Levels of alpha fetoprotein in serum
measure: Ultrasound
time frame: October 2018-February 2019
description: Results of the ultrasound examination
measure: AAb AFP
time frame: October 2018-February 2019
description: Titer of autoantibodies against alpha fetoprotein with standard protocol
arm group label: HCC
description: Patients with diagnosis of Hepatocellular carcinoma
arm group label: Cirrhosis
description: Patients with the diagnosis of cirrhosis who is following a screening program for diagnosis of HCC
arm group label: Chronic liver diseases
description: Patients with the diagnosis of Chronic liver diseases without cirrhosis
arm group label: Control
description: Normal human serum from donors without liver disease
intervention type: Diagnostic Test
intervention name: Test Yliver
description: Test Yliver is used to detect autoantibodies against alpha fetoprotein in serum by an ELISA technique
arm group label: Chronic liver diseases
arm group label: Cirrhosis
arm group label: Control
arm group label: HCC
Serum
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Corporacion Parc Tauli
investigator full name: Juan Francisco Delgado de la Poza
investigator title: Senior Immunologist
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
sharing ipd: No