<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/NCT03819400</url>
  </required_header>
  <id_info>
    <org_study_id>RIPH3-RNI18-Elastogreffe</org_study_id>
    <nct_id>NCT03819400</nct_id>
  </id_info>
  <brief_title>Evaluation of Kidney Graft's Fibrosis With Real Time Shear-wave Elastography</brief_title>
  <acronym>Elastogreffe</acronym>
  <official_title>Evaluation of Kidney Graft's Fibrosis With Real Time Shear-wave Elastography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Tours</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Tours</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>
      Kidney graft's fibrosis is correlated with prognostic of kidney's graft, wathever the initial&#xD;
      etiology. Actually, that evaluation is based on histologic score of Banff FI/AT (0 to III).&#xD;
      It is obtained thanks to punction-biopsy, which is invasive and can lead complications. This&#xD;
      exam is systematic on M3 of the transplantation.&#xD;
&#xD;
      Tissue's fibrosis is a proliferation of extracellular matrix, leading to an increase of&#xD;
      fibrosed tissue rigidity.&#xD;
&#xD;
      Elastography is an ultrasound technique allowing evaluation of tissues' rigidity.&#xD;
&#xD;
      The purpose is the validation of elastograhpy, innovative and non -invasive technique, and&#xD;
      more specifically Shear Wave Elastography (SWE). For this, strain ratio (SR) could improve&#xD;
      intra-operator variability and estimate fibrosis' degree of kidney's graft.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Kidney graft's fibrosis is correlated with prognostic of kidney's graft, wathever the initial&#xD;
      etiology. Actually, that evaluation is based on histologic score of Banff FI/AT (0 to III).&#xD;
      It is obtained thanks to punction-biopsy, which is invasive and can lead complications. This&#xD;
      exam is systematic on M3 of the transplantation.&#xD;
&#xD;
      Tissue's fibrosis is a proliferation of extracellular matrix, leading to an increase of&#xD;
      fibrosed tissue rigidity.&#xD;
&#xD;
      Elastography is an ultrasound technique allowing evaluation of tissues' rigidity.&#xD;
&#xD;
      The purpose is the validation of elastograhpy, innovative and non -invasive technique, and&#xD;
      more specifically Shear Wave Elastography (SWE). For this, strain ratio (SR) could improve&#xD;
      intra-operator variability and estimate fibrosis' degree of kidney's graft.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 29, 2019</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Anticipated">December 25, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>measure of shear wave elastography</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluation of shear wave elastography real time as biomarker of kidney graft's fibrosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Strain Ratio measure</measure>
    <time_frame>3 months</time_frame>
    <description>- Intra-operator variability of Strain Ratio measure</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Kidney Graft</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Kidney-transplanted patient&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Kidney-transplanted patient, whatever kind of organ donation ( alive donor, deceased&#xD;
             donor included extended criteria Maastricht 2 or 3)&#xD;
&#xD;
          -  More than 18 years-old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dual kidney graft&#xD;
&#xD;
          -  Hydronephrosis / urinary obstacle&#xD;
&#xD;
          -  Pathologies with an intrinsic compression on the graft&#xD;
&#xD;
          -  Stenosis hemodynamically significant of graft artery (lengthening of Systolic Ascent&#xD;
             Time &gt; 70 ms)&#xD;
&#xD;
          -  Contra-indication to systematical punction-biopsy on Month 3 :&#xD;
&#xD;
               -  Ischemia of post-transplanted graft&#xD;
&#xD;
               -  Alive donor HLA identical&#xD;
&#xD;
               -  Hemostasis disorder or unable to stop antiaggregant or anticoagulant&#xD;
&#xD;
               -  Hydronephrosis / urinary obstacle&#xD;
&#xD;
          -  Opposition to use the data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Corneliu Gradinaru, MD</last_name>
    <phone>02 47 38 67 92</phone>
    <email>c.gradinaru@chu-tours.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chu Tours</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Corneliu GRADINARU, MD</last_name>
      <email>c.gradinaru@chu-tours.fr</email>
    </contact>
    <investigator>
      <last_name>Corneliu GRADINARU, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>March 17, 2023</last_update_submitted>
  <last_update_submitted_qc>March 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>kidney graft</keyword>
  <keyword>fibrosis</keyword>
  <keyword>elastography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03819400
org study id: RIPH3-RNI18-Elastogreffe
nct id: NCT03819400
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Kidney graft's fibrosis is correlated with prognostic of kidney's graft, wathever the initial
      etiology. Actually, that evaluation is based on histologic score of Banff FI/AT (0 to III).
      It is obtained thanks to punction-biopsy, which is invasive and can lead complications. This
      exam is systematic on M3 of the transplantation.

      Tissue's fibrosis is a proliferation of extracellular matrix, leading to an increase of
      fibrosed tissue rigidity.

      Elastography is an ultrasound technique allowing evaluation of tissues' rigidity.

      The purpose is the validation of elastograhpy, innovative and non -invasive technique, and
      more specifically Shear Wave Elastography (SWE). For this, strain ratio (SR) could improve
      intra-operator variability and estimate fibrosis' degree of kidney's graft.
Kidney graft's fibrosis is correlated with prognostic of kidney's graft, wathever the initial
      etiology. Actually, that evaluation is based on histologic score of Banff FI/AT (0 to III).
      It is obtained thanks to punction-biopsy, which is invasive and can lead complications. This
      exam is systematic on M3 of the transplantation.

      Tissue's fibrosis is a proliferation of extracellular matrix, leading to an increase of
      fibrosed tissue rigidity.

      Elastography is an ultrasound technique allowing evaluation of tissues' rigidity.

      The purpose is the validation of elastograhpy, innovative and non -invasive technique, and
      more specifically Shear Wave Elastography (SWE). For this, strain ratio (SR) could improve
      intra-operator variability and estimate fibrosis' degree of kidney's graft.
observational model: Case-Only
time perspective: Prospective
measure: measure of shear wave elastography
time frame: 3 months
description: Evaluation of shear wave elastography real time as biomarker of kidney graft's fibrosis
measure: Strain Ratio measure
time frame: 3 months
description: - Intra-operator variability of Strain Ratio measure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Corneliu Gradinaru, MD
phone: 02 47 38 67 92
email: c.gradinaru@chu-tours.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Fibrosis
sharing ipd: Undecided