<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/NCT03000621</url>
  </required_header>
  <id_info>
    <org_study_id>Uestc500</org_study_id>
    <nct_id>NCT03000621</nct_id>
  </id_info>
  <brief_title>Comparative Study of Circulating microRNA Changes in Patients With Liver Injury and Healthy Subjects</brief_title>
  <official_title>Comparative Study of Circulating microRNA Changes in Patients With Liver Injury and Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Electronic Science and Technology of China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chengdu Nuoen Biotechnologies, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sichuan Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Electronic Science and Technology of China</source>
  <brief_summary>
    <textblock>
      The objectives are to:&#xD;
&#xD;
        1. validate a panel of tissue-specific miRNAs that are differentially expressed in the&#xD;
           plasma of patients with and without liver injuries&#xD;
&#xD;
        2. investigate the physiological range of the circulating miRNA panel in Healthy Subjects&#xD;
           and under stress&#xD;
&#xD;
        3. investigate the dysregulation of circulating miRNA panel and their prognostic and&#xD;
           predictive values in clinical outcomes in identifying patients at high risk for&#xD;
           mortality and acute liver failure.&#xD;
&#xD;
      This trial involves peripheral blood sampling from subjects at their earliest presentation&#xD;
      and remaining stays in the hospitalization in the emergency department. The investigators&#xD;
      will develop panels of miRNAs that are specific indicator of early onset of major organ&#xD;
      failures, and correlate clinical outcomes with these miRNAs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ICU patients after surgery or under chemotherapies in sponsor's institutes will be&#xD;
      enrolled in this observational cohort of investigation. Whole blood samples will be separated&#xD;
      immediately into plasma for storage. The participants will have their 2nd and 3rd samples&#xD;
      obtained at 24-48 hours and 48-72 hours respectively. The schedule of most of sampling&#xD;
      schedule is designed in concordance with the ICU routines to avoid extra burdens on patients.&#xD;
      The plasma samples will be used as prognostic markers in prognostic and predictive values in&#xD;
      identifying patients at high risk for mortality and acute liver failure. Patients who are&#xD;
      discharged will be tracked for any clinical recurrence of the diseases every 28 days to&#xD;
      assess the diagnostic accuracy of the miRNA biomarkers that are measured.&#xD;
&#xD;
      The 2nd objective will be assessed by measuring the concentration of miRNAs in recruited&#xD;
      healthy volunteers before and after a brief public speech. The circulating miRNAs will be&#xD;
      detected directly from 1 - 5 ul of plasma samples with the miRFLP assay. This capillary&#xD;
      electrophoresis-based miRNA quantification method detects multiple miRNAs in absolute copy&#xD;
      number in smaller sample signature with negligible batch to batch variation, thus providing a&#xD;
      standardizable miRNA detection method.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>The concentration of circulating miRNA expression quantitated in absolute copy numbers in ICU patients and their correlation with liver failure</measure>
    <time_frame>Three years</time_frame>
    <description>The concentration of circulating miRNAs in absolute quantification in comparison to the severity of liver injury (control vs. liver injury vs. acute liver injury). To investigate the potential prognosis of liver failure by the expression difference of the miRNA panel at the onset of liver injury. Sensitivity, specificity and the potential scopes of selected miRNA in the miRNA panel to distinguish different severity of liver injury and against standard clinical parameters, serum amonotransferases (ALT, AST), total bilirubin measurement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The possible physiological range of selected miRNAs in healthy subjects and the performance metrics of the miRNA detection methodology</measure>
    <time_frame>Three years</time_frame>
    <description>The concentration of circulating miRNAs in healthy subjects under resting condition and/or under stress. To investigate the potential physiological levels of the miRNA panel in healthy control as baselines.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Drug-Induced Liver Injury</condition>
  <condition>Liver Failure</condition>
  <arm_group>
    <arm_group_label>Patients with liver injury</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood extraction from subjects subsequently separated to plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        This research project will recruit a cohort of prospective observational cancer patients in&#xD;
        ICU after surgery or chemotherapy. Admitted patients will be followed-up in the inpatient&#xD;
        units in concordance with ICU protocols. Upon discharged, patients will be followed-up in&#xD;
        every 28 days for any disease recurrence and clinical outcomes. Healthy controls will also&#xD;
        be recruited to demonstrate the physiological level of different circulating miRNAs.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria for healthy controls:&#xD;
&#xD;
        Adults 18 years and above&#xD;
&#xD;
        Exclusion criteria for healthy controls:&#xD;
&#xD;
        Underlying chronic inflammatory condition (e.g. inflammatory bowel disease) Underlying&#xD;
        autoimmune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus) Pre-existent&#xD;
        liver disorder User of any prescribed medicine or over the counter drugs in prior 7 days.&#xD;
&#xD;
        Inclusion criteria for subjects:&#xD;
&#xD;
        Adults 18 years and above Has condition related to ICU enrollment cause&#xD;
&#xD;
        Exclusion criteria for subjects:&#xD;
&#xD;
        Age below 18 years Known pregnancy Treating physician deems aggressive care unsuitable&#xD;
        Unable to provide informed consent or comply with study requirements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Huang Jian, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Electronic Science and Technology of China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kang Juanjuan</last_name>
    <phone>+ 86-28-83202351</phone>
    <email>kjj@immunet.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Electronic Science and Technology of China</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610054</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Huang Jian, Ph.D</last_name>
      <phone>+ 86-28-83202351</phone>
      <email>hj@uestc.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>December 17, 2016</study_first_submitted>
  <study_first_submitted_qc>December 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>May 24, 2017</last_update_submitted>
  <last_update_submitted_qc>May 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MicroRNA</keyword>
  <keyword>miR-122</keyword>
  <keyword>Diagnosis</keyword>
  <keyword>Prognosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Failure</mesh_term>
    <mesh_term>Chemical and Drug Induced Liver Injury</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT03000621
org study id: Uestc500
nct id: NCT03000621
lead sponsor: 
collaborator: 
collaborator: 
The objectives are to:

        1. validate a panel of tissue-specific miRNAs that are differentially expressed in the
           plasma of patients with and without liver injuries

        2. investigate the physiological range of the circulating miRNA panel in Healthy Subjects
           and under stress

        3. investigate the dysregulation of circulating miRNA panel and their prognostic and
           predictive values in clinical outcomes in identifying patients at high risk for
           mortality and acute liver failure.

      This trial involves peripheral blood sampling from subjects at their earliest presentation
      and remaining stays in the hospitalization in the emergency department. The investigators
      will develop panels of miRNAs that are specific indicator of early onset of major organ
      failures, and correlate clinical outcomes with these miRNAs.
The ICU patients after surgery or under chemotherapies in sponsor's institutes will be
      enrolled in this observational cohort of investigation. Whole blood samples will be separated
      immediately into plasma for storage. The participants will have their 2nd and 3rd samples
      obtained at 24-48 hours and 48-72 hours respectively. The schedule of most of sampling
      schedule is designed in concordance with the ICU routines to avoid extra burdens on patients.
      The plasma samples will be used as prognostic markers in prognostic and predictive values in
      identifying patients at high risk for mortality and acute liver failure. Patients who are
      discharged will be tracked for any clinical recurrence of the diseases every 28 days to
      assess the diagnostic accuracy of the miRNA biomarkers that are measured.

      The 2nd objective will be assessed by measuring the concentration of miRNAs in recruited
      healthy volunteers before and after a brief public speech. The circulating miRNAs will be
      detected directly from 1 - 5 ul of plasma samples with the miRFLP assay. This capillary
      electrophoresis-based miRNA quantification method detects multiple miRNAs in absolute copy
      number in smaller sample signature with negligible batch to batch variation, thus providing a
      standardizable miRNA detection method.
observational model: Cohort
time perspective: Prospective
measure: The concentration of circulating miRNA expression quantitated in absolute copy numbers in ICU patients and their correlation with liver failure
time frame: Three years
description: The concentration of circulating miRNAs in absolute quantification in comparison to the severity of liver injury (control vs. liver injury vs. acute liver injury). To investigate the potential prognosis of liver failure by the expression difference of the miRNA panel at the onset of liver injury. Sensitivity, specificity and the potential scopes of selected miRNA in the miRNA panel to distinguish different severity of liver injury and against standard clinical parameters, serum amonotransferases (ALT, AST), total bilirubin measurement.
measure: The possible physiological range of selected miRNAs in healthy subjects and the performance metrics of the miRNA detection methodology
time frame: Three years
description: The concentration of circulating miRNAs in healthy subjects under resting condition and/or under stress. To investigate the potential physiological levels of the miRNA panel in healthy control as baselines.
arm group label: Patients with liver injury
arm group label: Healthy subjects
Whole blood extraction from subjects subsequently separated to plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Huang Jian, PhD
role: Principal Investigator
affiliation: University of Electronic Science and Technology of China
last name: Kang Juanjuan
phone: + 86-28-83202351
email: kjj@immunet.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Liver Failure
mesh term: Chemical and Drug Induced Liver Injury
mesh term: Wounds and Injuries