xml: <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/NCT06013358</url>
    </required_header>
    <id_info>
      <org_study_id>SNUH-ddcfDNA-KT-V1.4</org_study_id>
      <nct_id>NCT06013358</nct_id>
    </id_info>
    <brief_title>ddcfDNA in Kidney Transplant Recipients</brief_title>
    <official_title>The Efficacy of Donor-derived Cell-free DNA as a Biomarker for Subclinical Antibody-mediated Rejection in de Novo Anti-HLA DSA-positive Recipients Who Maintain Stable Renal Function After Kidney Transplantation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seoul National University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Samsung Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Asan Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Severance Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Korea University Anam Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Seoul National University Hospital</source>
    <oversight_info>
      <has_dmc>No</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>
        The objective of this study is to predict subclinical Antibody-Mediated Rejection (ABMR)&#xD;
        occurrences in de novo DSA-positive recipients maintaining stable renal function after&#xD;
        transplantation. This will be achieved through the measurement of donor-derived cell-free&#xD;
        DNA. The utility of donor-derived cell-free DNA will be validated based on histological&#xD;
        findings using Receiver Operating Characteristics (ROC) curve analysis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 26, 2022</start_date>
    <completion_date type="Anticipated">February 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2024</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>diagnostic accuracy of subclinical ABMR</measure>
      <time_frame>10 years within kidney transplantation</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Kidney Transplant Rejection</condition>
    <intervention>
      <intervention_type>Genetic</intervention_type>
      <intervention_name>AlloSeq cfDNA</intervention_name>
      <description>An in vitro diagnostic medical device is employed for predicting damage to and rejection of transplanted organs (kidney, heart, liver, lung) by measuring the ratio of Donor-Derived Cell-Free DNA (dd-cfDNA) to total Cell-Free DNA (cfDNA) extracted from the plasma of patients who have undergone solid organ transplantation. This measurement is carried out using next-generation sequencing methods.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Recipients with de novo DSA positivity post-kidney transplantation maintaining stable renal&#xD;
          function&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Recipients aged 18 and above&#xD;
  &#xD;
            -  Patients with de novo DSA positivity post-kidney transplantation and stable renal&#xD;
               function: De novo HLA DSAs encompass both class I and class II, with Mean Fluorescence&#xD;
               Intensity (MFI) greater than 1000. Stable renal function is defined as serum&#xD;
               creatinine variation of less than 15% compared to the last 6 months.&#xD;
  &#xD;
            -  Patients with detected de novo HLA-DSAs but did not undergo histological examinations.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Multi-organ transplant recipients&#xD;
  &#xD;
            -  Recipients with positive preformed DSAs&#xD;
  &#xD;
            -  ABO-incompatible transplant recipients&#xD;
  &#xD;
            -  Pediatric recipients under 18 years old at the time of transplantation&#xD;
  &#xD;
            -  Recipients lost to follow-up observation&#xD;
  &#xD;
            -  atients already subjected to histological examinations due to positive De novo&#xD;
               HLA-DSAs.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Ara Jo, MD</last_name>
      <phone>82-10-7364-9899</phone>
      <email>ara501616@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Seoul National University Hospital</name>
        <address>
          <city>Seoul</city>
          <zip>110-744</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sang-Il Min, MD</last_name>
        <phone>82-2-2072-2330</phone>
        <email>surgeonmsi@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013358
  org study id: SNUH-ddcfDNA-KT-V1.4
  nct id: NCT06013358
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study is to predict subclinical Antibody-Mediated Rejection (ABMR)
        occurrences in de novo DSA-positive recipients maintaining stable renal function after
        transplantation. This will be achieved through the measurement of donor-derived cell-free
        DNA. The utility of donor-derived cell-free DNA will be validated based on histological
        findings using Receiver Operating Characteristics (ROC) curve analysis.
  observational model: Cohort
  time perspective: Prospective
  measure: diagnostic accuracy of subclinical ABMR
  time frame: 10 years within kidney transplantation
  intervention type: Genetic
  intervention name: AlloSeq cfDNA
  description: An in vitro diagnostic medical device is employed for predicting damage to and rejection of transplanted organs (kidney, heart, liver, lung) by measuring the ratio of Donor-Derived Cell-Free DNA (dd-cfDNA) to total Cell-Free DNA (cfDNA) extracted from the plasma of patients who have undergone solid organ transplantation. This measurement is carried out using next-generation sequencing methods.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Ara Jo, MD
  phone: 82-10-7364-9899
  email: ara501616@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Korea, Republic of
  responsible party type: Sponsor
  sharing ipd: No