<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/NCT03804593</url>
  </required_header>
  <id_info>
    <org_study_id>Epigenomics 2018-HCC-A</org_study_id>
    <nct_id>NCT03804593</nct_id>
  </id_info>
  <brief_title>HCCBloodTest for Detection of Hepatocellular Carcinoma (HCC)</brief_title>
  <official_title>HCCBloodTest for Detection of Hepatocellular Carcinoma (HCC): Marker Performance Validation and Technical Development Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Epigenomics, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Innovis LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Epigenomics, Inc</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a multi-center study to prospectively gather clinically-characterized plasma samples&#xD;
      to determine the diagnostic performance characteristics (sensitivity and specificity) of the&#xD;
      HCCBloodTest among patients with cirrhosis with and without HCC&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with clinically-diagnosed cirrhosis without HCC (Group 1) and patients with&#xD;
      early-stage HCC (Group 2) will be invited to participate in this study consisting of one&#xD;
      visit for all subjects. At Visit 1, Day 0, after subjects have provided informed consent and&#xD;
      HIPAA consent, demographics (age, gender, ethnicity), etiology of liver disease and medical&#xD;
      history as well as a list of current medications will be obtained; inclusion and exclusion&#xD;
      criteria will be reviewed; and subjects will be registered into the study and will undergo a&#xD;
      venipuncture to obtain four (4) lavender top K2 ethylenediaminetetraacetic acid (EDTA) 10&#xD;
      millilitre (mL) tubes of blood.&#xD;
&#xD;
      The HCCBloodTest will be performed on the blood samples collected from study subjects by the&#xD;
      Sponsor at its laboratory in Berlin, Germany, to determine the performance characteristics of&#xD;
      the HCCBloodTest in the study population.&#xD;
&#xD;
      The HCCBloodTest is an in-vitro polymerase chain reaction (PCR) assay for the qualitative&#xD;
      detection of Septin 9 gene methylation (SEPT9) in DNA isolated from 3.5 mL of patient plasma.&#xD;
      The SEPT9 gene is a key regulator of cell division and tumor suppressor and the&#xD;
      hypermethylation of the assessed marker site is associated with liver carcinogenesis.&#xD;
&#xD;
      Results from the HCCBloodTest will be not be provided to the investigators or study subjects&#xD;
      and, therefore, will be not be used in clinical decision-making or impact clinical care of&#xD;
      the study participants in any manner.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Actual">October 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 1, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of SEPT9 gene promoter methylation positivity in patients with cirrhosis, based on the HCCBloodTest.</measure>
    <time_frame>45 days</time_frame>
    <description>The HCCBloodTest is an in-vitro PCR based assay for the qualitative detection of the methylation status of a SEPT9 gene promoter DNA sequence. Plasma will be prepared from blood samples collected from study subjects and will be tested by the Sponsor with HCCBloodTest at its laboratory in Berlin, Germany. Positivity based on PCR results will be reported for study subjects. Test performance characteristics including sensitivity and specificity will be reported for the study population.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">175</enrollment>
  <condition>Cirrhosis, Liver</condition>
  <condition>Hepatic Cirrhosis</condition>
  <condition>Hepatocellular Carcinoma</condition>
  <condition>Liver Cancer</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Diagnosis of cirrhosis and no HCC confirmed by medical imaging including MRI or CT performed within 6 months of study enrollment. If lesions are present, a Liver Imaging Reporting and Data System (LI-RADS) score of LR-1 or LR-2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>Diagnosis of HCC confirmed by medical imaging (MRI or CT performed within 6 months of study enrollment with LI-RADS score of LR-5) and/or biopsy with histopathology.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      De-identified, clinically characterized plasma specimens for a bio-repository will be&#xD;
      retained for up to twenty (20) years for future HCC-related test development.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Eligible subjects will be men and women age 18 years or older. Study will enroll sufficient&#xD;
        subjects to yield a minimum of 100 evaluable subjects in Group 1, a minimum of 100&#xD;
        evaluable subjects with de novo HCC and cirrhosis in Group 2 and up to 20 subjects with de&#xD;
        novo HCC without cirrhosis in Group 2 - a total of up to 220 evaluable study subjects who&#xD;
        meet all inclusion and exclusion criteria for these two groups.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or women age 18 years or older;&#xD;
&#xD;
          -  Able to read, understand and sign informed consent to participate in study;&#xD;
&#xD;
          -  Willing and able to provide written informed consent;&#xD;
&#xD;
          -  Willing and able to meet all study requirements and undergo venipuncture to provide&#xD;
             blood samples;&#xD;
&#xD;
          -  Child-Pugh Score of A or B.&#xD;
&#xD;
        Group 1:&#xD;
&#xD;
        • Diagnosis of cirrhosis and no HCC confirmed by abdominal contrast-enhanced MRI or CT&#xD;
        study performed &lt; 90 days prior to the date of consent or an MRI performed ≤ 45 days after&#xD;
        Visit 1. If lesions are present, a LI-RADS score of LR-1 or LR-2.&#xD;
&#xD;
        Group 2:&#xD;
&#xD;
        • Diagnosis of HCC confirmed by abdominal contrast-enhanced MRI or CT study performed &lt; 90&#xD;
        days prior to the date of consent or an MRI performed ≤ 45 days after Visit 1 with LI-RADS&#xD;
        score of LR-5 and/or biopsy with histopathology.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Both Groups:&#xD;
&#xD;
          -  Child-Pugh Score of C;&#xD;
&#xD;
          -  Subject has undergone a colonoscopy, endoscopy or other invasive diagnostic procedure&#xD;
             (other than venipuncture) during the 10 days prior to providing a blood sample for&#xD;
             this study;&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  Breastfeeding;&#xD;
&#xD;
          -  Currently undergoing dialysis;&#xD;
&#xD;
          -  Currently receiving investigational treatments of any type;&#xD;
&#xD;
          -  History of receiving any drug therapy, surgery or liver transplant for the treatment&#xD;
             of HCC;&#xD;
&#xD;
          -  Diagnosis of any non-HCC cancer (other than non-melanoma skin cancer) within past 5&#xD;
             years and/or currently undergoing treatment for any cancer;&#xD;
&#xD;
          -  Any clinical condition, diagnosis, or social circumstance that, in the opinion of the&#xD;
             Investigator, would be mean participation in the study would be contraindicated.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Theo DeVos</last_name>
    <role>Study Director</role>
    <affiliation>Epigenomics, Inc</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nick Potter</last_name>
    <role>Study Director</role>
    <affiliation>Epigenomics, Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USC Keck Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Liver Research Institute</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 28, 2020</last_update_submitted>
  <last_update_submitted_qc>January 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03804593
org study id: Epigenomics 2018-HCC-A
nct id: NCT03804593
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a multi-center study to prospectively gather clinically-characterized plasma samples
      to determine the diagnostic performance characteristics (sensitivity and specificity) of the
      HCCBloodTest among patients with cirrhosis with and without HCC
Patients with clinically-diagnosed cirrhosis without HCC (Group 1) and patients with
      early-stage HCC (Group 2) will be invited to participate in this study consisting of one
      visit for all subjects. At Visit 1, Day 0, after subjects have provided informed consent and
      HIPAA consent, demographics (age, gender, ethnicity), etiology of liver disease and medical
      history as well as a list of current medications will be obtained; inclusion and exclusion
      criteria will be reviewed; and subjects will be registered into the study and will undergo a
      venipuncture to obtain four (4) lavender top K2 ethylenediaminetetraacetic acid (EDTA) 10
      millilitre (mL) tubes of blood.

      The HCCBloodTest will be performed on the blood samples collected from study subjects by the
      Sponsor at its laboratory in Berlin, Germany, to determine the performance characteristics of
      the HCCBloodTest in the study population.

      The HCCBloodTest is an in-vitro polymerase chain reaction (PCR) assay for the qualitative
      detection of Septin 9 gene methylation (SEPT9) in DNA isolated from 3.5 mL of patient plasma.
      The SEPT9 gene is a key regulator of cell division and tumor suppressor and the
      hypermethylation of the assessed marker site is associated with liver carcinogenesis.

      Results from the HCCBloodTest will be not be provided to the investigators or study subjects
      and, therefore, will be not be used in clinical decision-making or impact clinical care of
      the study participants in any manner.
observational model: Case-Control
time perspective: Prospective
measure: Rate of SEPT9 gene promoter methylation positivity in patients with cirrhosis, based on the HCCBloodTest.
time frame: 45 days
description: The HCCBloodTest is an in-vitro PCR based assay for the qualitative detection of the methylation status of a SEPT9 gene promoter DNA sequence. Plasma will be prepared from blood samples collected from study subjects and will be tested by the Sponsor with HCCBloodTest at its laboratory in Berlin, Germany. Positivity based on PCR results will be reported for study subjects. Test performance characteristics including sensitivity and specificity will be reported for the study population.
arm group label: Group 1
description: Diagnosis of cirrhosis and no HCC confirmed by medical imaging including MRI or CT performed within 6 months of study enrollment. If lesions are present, a Liver Imaging Reporting and Data System (LI-RADS) score of LR-1 or LR-2.
arm group label: Group 2
description: Diagnosis of HCC confirmed by medical imaging (MRI or CT performed within 6 months of study enrollment with LI-RADS score of LR-5) and/or biopsy with histopathology.
De-identified, clinically characterized plasma specimens for a bio-repository will be
      retained for up to twenty (20) years for future HCC-related test development.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Theo DeVos
role: Study Director
affiliation: Epigenomics, Inc
last name: Nick Potter
role: Study Director
affiliation: Epigenomics, Inc
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
mesh term: Liver Cirrhosis
mesh term: Fibrosis