<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/NCT04477967</url>
  </required_header>
  <id_info>
    <org_study_id>2018（120）</org_study_id>
    <nct_id>NCT04477967</nct_id>
  </id_info>
  <brief_title>Design and Implementation of the Pediatric Liver Transplantation Biobank</brief_title>
  <official_title>Children's Hospital of Chongqing Medical University</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital of Chongqing Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the pediatric liver transplant biobank is to systematically collect clinical&#xD;
      specimens from pediatric end-stage liver disease. It is expected to contribute to the&#xD;
      research and development of paediatric end-stage liver disease in the future.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">July 1, 2028</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Biological sample bank</measure>
    <time_frame>2 years</time_frame>
    <description>A repository of biological samples from patients who will join the project, will be organised at the biobank center of the Children's Hospital of Chongqing Medical University(CHCMU) under the responsibility of the experienced staff at the Department of Hepatic.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Integrated health data platform</measure>
    <time_frame>2 years</time_frame>
    <description>Collect patient clinical test information and establish diagnostic database.</description>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Liver Diseases</condition>
  <condition>Liver Transplant; Complications</condition>
  <condition>Pediatric ALL</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>There are no interventions because it is a protocol study</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children with end-stage liver disease who undergo liver transplantation in our hospital.&#xD;
        Obtain their or their parents' informed consent before the project starts.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Children diagnosed with end-stage liver disease.&#xD;
&#xD;
          2. Liver transplantation in our hospital.&#xD;
&#xD;
          3. informed patient consent.&#xD;
&#xD;
          4. long-term follow-up in our hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        No fixed contact information, difficult to follow up the patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xiang Zheng</last_name>
    <phone>17723191712</phone>
    <email>xiangzheng061@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Children's Hospital of Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400014</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yao Zhao, postdoctor</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital of Chongqing Medical University</investigator_affiliation>
    <investigator_full_name>Qiu Li</investigator_full_name>
    <investigator_title>dean</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</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/NCT04477967
org study id: 2018（120）
nct id: NCT04477967
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of the pediatric liver transplant biobank is to systematically collect clinical
      specimens from pediatric end-stage liver disease. It is expected to contribute to the
      research and development of paediatric end-stage liver disease in the future.
observational model: Cohort
time perspective: Prospective
measure: Biological sample bank
time frame: 2 years
description: A repository of biological samples from patients who will join the project, will be organised at the biobank center of the Children's Hospital of Chongqing Medical University(CHCMU) under the responsibility of the experienced staff at the Department of Hepatic.
measure: Integrated health data platform
time frame: 2 years
description: Collect patient clinical test information and establish diagnostic database.
intervention type: Other
intervention name: No intervention
description: There are no interventions because it is a protocol study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Xiang Zheng
phone: 17723191712
email: xiangzheng061@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Children's Hospital of Chongqing Medical University
investigator full name: Qiu Li
investigator title: dean
mesh term: Liver Diseases