<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/NCT03277651</url>
  </required_header>
  <id_info>
    <org_study_id>Hemodynamics Models for CLD</org_study_id>
    <nct_id>NCT03277651</nct_id>
  </id_info>
  <brief_title>Noninvasive Diagnostic Platform for Liver Fibrosis and Portal Hypertension</brief_title>
  <official_title>Developing a Hemodynamics Based Noninvasive Diagnostic Platform for Liver Fibrosis/Cirrhosis and Portal Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</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>
      This study is to establish a noninvasive diagnostic platform based on hemodynamic information&#xD;
      for the assessment of liver fibrosis, liver cirrhosis and portal hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As the hemodynamics of liver vessels depend on the liver tissue mechanics, we hypothesize&#xD;
      that the hemodynamics measurements of the liver are strongly correlated with the stages of&#xD;
      liver fibrosis and portal hypertension, and can therefore serve as an alternative means of&#xD;
      diagnosis. We have developed a physics-based mathematical model that incorporates our&#xD;
      biological understanding of fibrosis development. The model quantitatively predicts changes&#xD;
      of liver tissue stiffness and blood flow dynamics as a function of fibrosis stage.&#xD;
      Preliminary data using ultrasound Doppler images and needle biopsy from liver fibrosis&#xD;
      patients have suggested the 'prove of principle. We propose further test our hypothesis by&#xD;
      collecting and analyzing ultrasound Doppler and biopsy data to confirm the correlation&#xD;
      between blood flow dynamics and disease stage from patients with hepatic fibrosis and portal&#xD;
      hypertension. If tested true, we can expect to use features of ultrasound Doppler as a&#xD;
      non-invasive means of diagnosis for fibrosis and portal hypertension.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 9, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity</measure>
    <time_frame>baseline</time_frame>
    <description>Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Specificity</measure>
    <time_frame>baseline</time_frame>
    <description>Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive predictive value (PPV)</measure>
    <time_frame>baseline</time_frame>
    <description>Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Negative predictive value (NPV)</measure>
    <time_frame>baseline</time_frame>
    <description>Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under ROC curve (AUROC)</measure>
    <time_frame>baseline</time_frame>
    <description>Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Liver Fibrosis</condition>
  <condition>Cirrhosis</condition>
  <condition>Portal Hypertension</condition>
  <arm_group>
    <arm_group_label>liver fibrosis</arm_group_label>
    <description>liver biopsy proved</description>
  </arm_group>
  <arm_group>
    <arm_group_label>portal hypertension</arm_group_label>
    <description>hepatic venous pressure gradient (HVPG) proved</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>hemodynamics tests</intervention_name>
    <description>Hemodynamics tests for intrahepatic blood flow by colour doppler ultrasound</description>
    <arm_group_label>liver fibrosis</arm_group_label>
    <arm_group_label>portal hypertension</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Inpatients who undergo liver biopsy or hepatic venous pressure gradient test in Zhongshan&#xD;
        hospital Fudan University&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inpatients who undergo liver biopsy or hepatic venous pressure gradient test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  decompensated liver diseases (including ascites, variceal bleeding or hepatic&#xD;
             encephalopathy);&#xD;
&#xD;
          -  alpha-fetoprotein &gt;100 ng/ml or serum creatinine &gt;1.5 × upper limit of normal (ULN);&#xD;
&#xD;
          -  any malignant tumor;&#xD;
&#xD;
          -  any complications of severe heart, lung, kidney, brain, blood diseases or other&#xD;
             important systematic diseases;&#xD;
&#xD;
          -  severe neurological or psychological disease;&#xD;
&#xD;
          -  pregnant or lactating women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei Jiang</last_name>
    <role>Study Chair</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shengdi Wu</last_name>
    <phone>0086-021-64041990</phone>
    <email>wu.shengdi@zs-hospital.sh.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wei Jiang</last_name>
    <phone>0086-021-64041990</phone>
    <email>jiang.wei@zs-hospital.sh.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Zhongshan Hospital affiliated to Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shengdi Wu, M.D.</last_name>
      <email>wu.shengdi@zs-hospital.sh.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>January 9, 2018</last_update_submitted>
  <last_update_submitted_qc>January 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>noninvasive</keyword>
  <keyword>Hemodynamics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Hypertension, Portal</mesh_term>
    <mesh_term>Hypertension</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/NCT03277651
org study id: Hemodynamics Models for CLD
nct id: NCT03277651
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is to establish a noninvasive diagnostic platform based on hemodynamic information
      for the assessment of liver fibrosis, liver cirrhosis and portal hypertension.
As the hemodynamics of liver vessels depend on the liver tissue mechanics, we hypothesize
      that the hemodynamics measurements of the liver are strongly correlated with the stages of
      liver fibrosis and portal hypertension, and can therefore serve as an alternative means of
      diagnosis. We have developed a physics-based mathematical model that incorporates our
      biological understanding of fibrosis development. The model quantitatively predicts changes
      of liver tissue stiffness and blood flow dynamics as a function of fibrosis stage.
      Preliminary data using ultrasound Doppler images and needle biopsy from liver fibrosis
      patients have suggested the 'prove of principle. We propose further test our hypothesis by
      collecting and analyzing ultrasound Doppler and biopsy data to confirm the correlation
      between blood flow dynamics and disease stage from patients with hepatic fibrosis and portal
      hypertension. If tested true, we can expect to use features of ultrasound Doppler as a
      non-invasive means of diagnosis for fibrosis and portal hypertension.
observational model: Cohort
time perspective: Prospective
measure: Sensitivity
time frame: baseline
description: Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension
measure: Specificity
time frame: baseline
description: Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension
measure: Positive predictive value (PPV)
time frame: baseline
description: Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension
measure: Negative predictive value (NPV)
time frame: baseline
description: Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension
measure: Area under ROC curve (AUROC)
time frame: baseline
description: Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension
arm group label: liver fibrosis
description: liver biopsy proved
arm group label: portal hypertension
description: hepatic venous pressure gradient (HVPG) proved
intervention type: Diagnostic Test
intervention name: hemodynamics tests
description: Hemodynamics tests for intrahepatic blood flow by colour doppler ultrasound
arm group label: liver fibrosis
arm group label: portal hypertension
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Wei Jiang
role: Study Chair
affiliation: Fudan University
last name: Shengdi Wu
phone: 0086-021-64041990
email: wu.shengdi@zs-hospital.sh.cn
last name: Wei Jiang
phone: 0086-021-64041990
email: jiang.wei@zs-hospital.sh.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Liver Cirrhosis
mesh term: Hypertension, Portal
mesh term: Hypertension
mesh term: Fibrosis