<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/NCT03820934</url>
  </required_header>
  <id_info>
    <org_study_id>12-17-09</org_study_id>
    <nct_id>NCT03820934</nct_id>
  </id_info>
  <brief_title>FibroScan ® Study: Assessing Liver Fibrosis in Patients Using Methotrexate for Psoriasis</brief_title>
  <official_title>A Prospective, Validation Study of FibroSURE™ and FibroScan® as Screening, Detection, and Monitoring Alternatives to Liver Biopsy for Methotrexate-induced Hepatic Fibrosis and Cirrhosis in Patients With Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospitals Cleveland Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospitals Cleveland Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to validate FibroScan and FibroSURE™ as equal or superior&#xD;
      alternatives to liver biopsy for the monitoring and detection of methotrexate-induced hepatic&#xD;
      fibrosis and cirrhosis in patients with moderate-to-severe psoriasis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goals of this study are to validate FibroScan and FibroSURE™ as equal or superior&#xD;
      alternatives to liver biopsy. The goal is to evaluate the monitoring and detection of&#xD;
      methotrexate-induced hepatic fibrosis and cirrhosis in patients with moderate-to-severe&#xD;
      psoriasis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Per Investigator study was terminated prematurely&#xD;
  </why_stopped>
  <start_date type="Actual">February 10, 2019</start_date>
  <completion_date type="Actual">May 15, 2019</completion_date>
  <primary_completion_date type="Actual">May 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fibrosis Score Correlation</measure>
    <time_frame>5 years</time_frame>
    <description>The correlation between the clinical fibrosis scores generated by the FibroScan® and FibroSURE™ alone and in combination to the METAVIR fibrosis score generated from the histologic review of a liver biopsy performed for the assessment of liver fibrosis in a psoriasis patient who reaches a cumulative methotrexate dose of 1g.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fibrosis Score Validity to Liver Biopsy Results</measure>
    <time_frame>5 years</time_frame>
    <description>Determine if the clinical fibrosis scores generated by the FibroScan® and FibroSURE™ alone and in combination can be safely used as alternatives to performing a liver biopsy when screening for liver fibrosis in psoriasis patients who have reached a cumulative methotrexate dose of 1 gram</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Patients undergoing Fibroscan and Fibrosure</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patient's will undergo fibroscan and fibrosure to test their liver for the level of liver fibrosis as measured by these test. The scores from these tests will then be compared to the amount of fibrosis noted on a standard of care liver biopsy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Fibroscan and Fibrosure</intervention_name>
    <description>Patient's will undergo fibroscan and fibrosure to test their liver for the level of liver fibrosis as measured by these tests. Fibroscan uses vibrations sent through the liver to measure its stiffness and the fibrosure uses laboratory and demographic parameters to create a score associated with a certain level of fibrosis. The scores from these tests will then be compared to the amount of fibrosis noted on a standard of care liver biopsy.</description>
    <arm_group_label>Patients undergoing Fibroscan and Fibrosure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female greater than or equal to 18 years of age&#xD;
&#xD;
          -  Must have a diagnosis of moderate-to-severe psoriasis&#xD;
&#xD;
          -  Newly starting methotrexate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to methotrexate&#xD;
&#xD;
          -  History of chronic alcohol abuse&#xD;
&#xD;
          -  Diagnosis of liver disease&#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>Neil Korman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals Cleveland Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospitals Cleveland Medical Center</investigator_affiliation>
    <investigator_full_name>Neil Korman</investigator_full_name>
    <investigator_title>Director, Clinical Trials Unit</investigator_title>
  </responsible_party>
  <keyword>Methotrexate</keyword>
  <keyword>FibroScan</keyword>
  <keyword>FibroSure</keyword>
  <keyword>Cirrhosis</keyword>
  <keyword>Fibrosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03820934
org study id: 12-17-09
nct id: NCT03820934
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to validate FibroScan and FibroSURE™ as equal or superior
      alternatives to liver biopsy for the monitoring and detection of methotrexate-induced hepatic
      fibrosis and cirrhosis in patients with moderate-to-severe psoriasis.
The goals of this study are to validate FibroScan and FibroSURE™ as equal or superior
      alternatives to liver biopsy. The goal is to evaluate the monitoring and detection of
      methotrexate-induced hepatic fibrosis and cirrhosis in patients with moderate-to-severe
      psoriasis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Fibrosis Score Correlation
time frame: 5 years
description: The correlation between the clinical fibrosis scores generated by the FibroScan® and FibroSURE™ alone and in combination to the METAVIR fibrosis score generated from the histologic review of a liver biopsy performed for the assessment of liver fibrosis in a psoriasis patient who reaches a cumulative methotrexate dose of 1g.
measure: Fibrosis Score Validity to Liver Biopsy Results
time frame: 5 years
description: Determine if the clinical fibrosis scores generated by the FibroScan® and FibroSURE™ alone and in combination can be safely used as alternatives to performing a liver biopsy when screening for liver fibrosis in psoriasis patients who have reached a cumulative methotrexate dose of 1 gram
arm group label: Patients undergoing Fibroscan and Fibrosure
arm group type: Other
description: Patient's will undergo fibroscan and fibrosure to test their liver for the level of liver fibrosis as measured by these test. The scores from these tests will then be compared to the amount of fibrosis noted on a standard of care liver biopsy.
intervention type: Diagnostic Test
intervention name: Fibroscan and Fibrosure
description: Patient's will undergo fibroscan and fibrosure to test their liver for the level of liver fibrosis as measured by these tests. Fibroscan uses vibrations sent through the liver to measure its stiffness and the fibrosure uses laboratory and demographic parameters to create a score associated with a certain level of fibrosis. The scores from these tests will then be compared to the amount of fibrosis noted on a standard of care liver biopsy.
arm group label: Patients undergoing Fibroscan and Fibrosure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Neil Korman, MD
role: Principal Investigator
affiliation: University Hospitals Cleveland Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University Hospitals Cleveland Medical Center
investigator full name: Neil Korman
investigator title: Director, Clinical Trials Unit
mesh term: Psoriasis
mesh term: Fibrosis
sharing ipd: Undecided