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/NCT05995379</url>
    </required_header>
    <id_info>
      <org_study_id>ddcfDNA_study001</org_study_id>
      <nct_id>NCT05995379</nct_id>
    </id_info>
    <brief_title>Donor Derived Cell-free DNA and Rejection of Kidney Allografts</brief_title>
    <official_title>Donor Derived Cell-free DNA and Rejection of Kidney Allografts</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Paris Translational Research Center for Organ Transplantation</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Paris Translational Research Center for Organ Transplantation</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>
        To assess the association of dd-cfDNA with the presence, activity and severity of allograft&#xD;
        rejection, and determine whether dd-cfDNA adds value to standard of care monitoring&#xD;
        parameters in detecting kidney allograft rejection.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 21, 2011</start_date>
    <completion_date type="Actual">August 9, 2022</completion_date>
    <primary_completion_date type="Actual">August 9, 2022</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 occurrence of biopsy-proven allograft rejection at the time of dd-cfDNA measurement</measure>
      <time_frame>The allograft biopsies will be performed at 3 months and 1 year after transplant and/or in for cause biopsies performed at any time post transplantation in unstable patients.</time_frame>
      <description>Biopsy-proven rejection refers to the confirmation of rejection through the examination of kidney allograft tissue obtained from a biopsy procedure. This includes different types of rejection, which are antibody-mediated rejection, T-cell-mediated rejection, and mixed rejection. All the allograft biopsies will be classified according to the most recognized classification (Banff 2019 classification), which provides standardized criteria for the diagnosis and the characterization of the different types of rejection.&#xD;
  To evaluate the association between dd-cfDNA and the occurrence of rejection, measurement of dd-cfDNA will be done at the time of each biopsy.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">2500</enrollment>
    <condition>Kidney Rejection Transplant</condition>
    <arm_group>
      <arm_group_label>Derivation cohort</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Validation cohort</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Donor-derived cell-free DNA</intervention_name>
      <description>Cell-free DNA (cfDNA) is fragmented extracellular DNA released in the bloodstream from cells undergoing apoptosis or necrosis. In transplantation, donor-derived cfDNA (dd-cfDNA) is detected in the blood of kidney recipients and has been proposed as a noninvasive biomarker to detect rejection.&#xD;
  One additional blood sample will be collected and dd-cfDNA levels will be centrally analyzed.</description>
      <arm_group_label>Derivation cohort</arm_group_label>
      <arm_group_label>Validation cohort</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Kidney transplant recipients recruited in 14 French centers&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Recipients transplanted from a deceased or living donor, who undergone a kidney&#xD;
               allograft biopsy with clinical, biological, histological and immunological data.&#xD;
  &#xD;
            -  Written informed consent at the time of transplantation for the center database&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Combined organ transplantation&#xD;
  &#xD;
            -  Pregnant women&#xD;
  &#xD;
            -  Bone marrow transplant&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alexandre Loupy</last_name>
      <role>Principal Investigator</role>
      <affiliation>Paris Institute for Transplantation and Organ Regeneration</affiliation>
    </overall_official>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>March 1, 2020</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT05995379/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05995379
  org study id: ddcfDNA_study001
  nct id: NCT05995379
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To assess the association of dd-cfDNA with the presence, activity and severity of allograft
        rejection, and determine whether dd-cfDNA adds value to standard of care monitoring
        parameters in detecting kidney allograft rejection.
  observational model: Cohort
  time perspective: Prospective
  measure: The occurrence of biopsy-proven allograft rejection at the time of dd-cfDNA measurement
  time frame: The allograft biopsies will be performed at 3 months and 1 year after transplant and/or in for cause biopsies performed at any time post transplantation in unstable patients.
  description: Biopsy-proven rejection refers to the confirmation of rejection through the examination of kidney allograft tissue obtained from a biopsy procedure. This includes different types of rejection, which are antibody-mediated rejection, T-cell-mediated rejection, and mixed rejection. All the allograft biopsies will be classified according to the most recognized classification (Banff 2019 classification), which provides standardized criteria for the diagnosis and the characterization of the different types of rejection.
  To evaluate the association between dd-cfDNA and the occurrence of rejection, measurement of dd-cfDNA will be done at the time of each biopsy.
  arm group label: Derivation cohort
  arm group label: Validation cohort
  intervention type: Diagnostic Test
  intervention name: Donor-derived cell-free DNA
  description: Cell-free DNA (cfDNA) is fragmented extracellular DNA released in the bloodstream from cells undergoing apoptosis or necrosis. In transplantation, donor-derived cfDNA (dd-cfDNA) is detected in the blood of kidney recipients and has been proposed as a noninvasive biomarker to detect rejection.
  One additional blood sample will be collected and dd-cfDNA levels will be centrally analyzed.
  arm group label: Derivation cohort
  arm group label: Validation cohort
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Year
  maximum age: N/A
  healthy volunteers: No
  last name: Alexandre Loupy
  role: Principal Investigator
  affiliation: Paris Institute for Transplantation and Organ Regeneration
  responsible party type: Sponsor
  provided document: 