<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/NCT02258048</url>
  </required_header>
  <id_info>
    <org_study_id>10-02236</org_study_id>
    <nct_id>NCT02258048</nct_id>
  </id_info>
  <brief_title>The Use of Transient Elastography to Predict Clinical Decompensation in Patients With Early Cirrhosis</brief_title>
  <official_title>The Use of Transient Elastography to Predict Clinical Decompensation in Patients With Early Cirrhosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective study designed to examine the role of transient elastography as a&#xD;
      predictor of clinical decompensation in patients with early cirrhosis. The study objective is&#xD;
      to determine if changes in measurements of liver stiffness with transient elastography can&#xD;
      identify patients that will have a more rapid progression of cirrhosis and the development of&#xD;
      clinical decompensation. The target population is patients with early stage, well-compensated&#xD;
      cirrhosis.&#xD;
&#xD;
      Participants of this study will be asked to complete the following procedures: read and sign&#xD;
      the informed consent, medical records review (complete medical history, physical examination,&#xD;
      laboratory evaluation, endoscopic findings, radiographic findings), undergo transient&#xD;
      elastography to measure liver stiffness every three months until the development of clinical&#xD;
      decompensation (ascites, variceal bleeding, hepatorenal syndrome, overt hepatic&#xD;
      encephalopathy) for up to 2 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective study designed to examine the role of transient elastography as a&#xD;
      predictor of clinical decompensation in patients with early cirrhosis. The study objective is&#xD;
      to determine if changes in measurements of liver stiffness with transient elastography can&#xD;
      identify patients that will have a more rapid progression of cirrhosis and the development of&#xD;
      clinical decompensation. The target population is patients with early stage, well-compensated&#xD;
      cirrhosis.&#xD;
&#xD;
      This study will attempt to determine if serial measurements of liver stiffness with transient&#xD;
      elastography in patients with early cirrhosis can identify patients at risk of morbidity or&#xD;
      mortality associated with hepatic decompensation.&#xD;
&#xD;
      For the Screening Visit, the following procedures will be performed:&#xD;
&#xD;
        1. Patient will read and sign informed consent. Subjects will be given sufficient time to&#xD;
           consider, ask questions, and sign the consent forms.&#xD;
&#xD;
        2. Patient will be assigned a subject number&#xD;
&#xD;
        3. Patient will be asked to provide demographic information&#xD;
&#xD;
        4. Patient will be asked to provide a complete medical history and laboratory evaluation&#xD;
&#xD;
        5. Physical examination including blood pressure, heart rate, height, and weight.&#xD;
&#xD;
        6. The following assessments will also be performed:&#xD;
&#xD;
             -  Calculation of modified Child Pugh Score: Using the following biochemical&#xD;
                variables: Serum Albumin, Total Bilirubin, Serum Creatinine, and INR.&#xD;
&#xD;
             -  MELD Score: Based on a continuous function of Bilirubin, INR, and Creatinine, which&#xD;
                uses a continuous variable ranging from 6-40.&#xD;
&#xD;
        7. 30cc of blood will be obtained, and serum frozen at -80C (freezer located in Dr. Sigal's&#xD;
           office) for up to 5 years. The blood will only be accessible to Dr. Sigal and his&#xD;
           research team. This blood may be analysed for known markers of liver disease, markers&#xD;
           that may be discovered in the future, and/or to identify new markers of liver disease.&#xD;
&#xD;
      For the Follow-Up Visits the following procedures will be performed every 3 months for up to&#xD;
      2 years:&#xD;
&#xD;
        1. An interim medical history will be obtained, with particular attention to the&#xD;
           development of clinical decompensation (ascites, variceal bleeding hepatorenal syndrome,&#xD;
           overt hepatic encephalopathy).&#xD;
&#xD;
        2. Physical examination.&#xD;
&#xD;
        3. Measurement of liver stiffness using hepatic elastography.&#xD;
&#xD;
        4. 30cc of blood will be obtained, and serum frozen for future analyses as above.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Samuel Sigal no longer with NYU&#xD;
  </why_stopped>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Liver Stiffness</measure>
    <time_frame>2 years</time_frame>
    <description>Liver stiffness will be measured using hepatic elastography.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evidence of Portal Hypertension</measure>
    <time_frame>2 years</time_frame>
    <description>Presence of significant portal hypertension will be determined by the presence of ascites or thrombocytopenia.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Cirrhosis</condition>
  <arm_group>
    <arm_group_label>Patients with cirrhosis</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Ambulatory patients with histologic or radiographic evidence of cirrhosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ambulatory patients with histologic or radiographic evidence of cirrhosis will be&#xD;
             screened for participation in the study.&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  MELD score &lt;10&#xD;
&#xD;
          -  No history of ascites, variceal bleeding, hepatorenal syndrome, overt hepatic&#xD;
             encephalopathy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of variceal bleeding, ascites, hepatorenal syndrome, or overt hepatic&#xD;
             encephalopathy&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Body mass index (BMI)&gt;35&#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>Samuel Sigal, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU Langone Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>March 9, 2016</last_update_submitted>
  <last_update_submitted_qc>March 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 10, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cirrhosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02258048
org study id: 10-02236
nct id: NCT02258048
lead sponsor: 
has dmc: No
This is a prospective study designed to examine the role of transient elastography as a
      predictor of clinical decompensation in patients with early cirrhosis. The study objective is
      to determine if changes in measurements of liver stiffness with transient elastography can
      identify patients that will have a more rapid progression of cirrhosis and the development of
      clinical decompensation. The target population is patients with early stage, well-compensated
      cirrhosis.

      Participants of this study will be asked to complete the following procedures: read and sign
      the informed consent, medical records review (complete medical history, physical examination,
      laboratory evaluation, endoscopic findings, radiographic findings), undergo transient
      elastography to measure liver stiffness every three months until the development of clinical
      decompensation (ascites, variceal bleeding, hepatorenal syndrome, overt hepatic
      encephalopathy) for up to 2 years.
This is a prospective study designed to examine the role of transient elastography as a
      predictor of clinical decompensation in patients with early cirrhosis. The study objective is
      to determine if changes in measurements of liver stiffness with transient elastography can
      identify patients that will have a more rapid progression of cirrhosis and the development of
      clinical decompensation. The target population is patients with early stage, well-compensated
      cirrhosis.

      This study will attempt to determine if serial measurements of liver stiffness with transient
      elastography in patients with early cirrhosis can identify patients at risk of morbidity or
      mortality associated with hepatic decompensation.

      For the Screening Visit, the following procedures will be performed:

        1. Patient will read and sign informed consent. Subjects will be given sufficient time to
           consider, ask questions, and sign the consent forms.

        2. Patient will be assigned a subject number

        3. Patient will be asked to provide demographic information

        4. Patient will be asked to provide a complete medical history and laboratory evaluation

        5. Physical examination including blood pressure, heart rate, height, and weight.

        6. The following assessments will also be performed:

             -  Calculation of modified Child Pugh Score: Using the following biochemical
                variables: Serum Albumin, Total Bilirubin, Serum Creatinine, and INR.

             -  MELD Score: Based on a continuous function of Bilirubin, INR, and Creatinine, which
                uses a continuous variable ranging from 6-40.

        7. 30cc of blood will be obtained, and serum frozen at -80C (freezer located in Dr. Sigal's
           office) for up to 5 years. The blood will only be accessible to Dr. Sigal and his
           research team. This blood may be analysed for known markers of liver disease, markers
           that may be discovered in the future, and/or to identify new markers of liver disease.

      For the Follow-Up Visits the following procedures will be performed every 3 months for up to
      2 years:

        1. An interim medical history will be obtained, with particular attention to the
           development of clinical decompensation (ascites, variceal bleeding hepatorenal syndrome,
           overt hepatic encephalopathy).

        2. Physical examination.

        3. Measurement of liver stiffness using hepatic elastography.

        4. 30cc of blood will be obtained, and serum frozen for future analyses as above.
observational model: Case-Only
time perspective: Prospective
measure: Liver Stiffness
time frame: 2 years
description: Liver stiffness will be measured using hepatic elastography.
measure: Evidence of Portal Hypertension
time frame: 2 years
description: Presence of significant portal hypertension will be determined by the presence of ascites or thrombocytopenia.
arm group label: Patients with cirrhosis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Samuel Sigal, M.D.
role: Principal Investigator
affiliation: NYU Langone Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Liver Cirrhosis
mesh term: Fibrosis