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/NCT06032364</url>
    </required_header>
    <id_info>
      <org_study_id>9020</org_study_id>
      <nct_id>NCT06032364</nct_id>
    </id_info>
    <brief_title>Stone Disease of the Urinary Tract in Children: Clinical Presentation, Diagnostic Methods, Therapeutic Management, Evolution and Prognosis</brief_title>
    <acronym>Ped-Urolithia</acronym>
    <official_title>Stone Disease of the Urinary Tract in Children: Clinical Presentation, Diagnostic Methods, Therapeutic Management, Evolution and Prognosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Strasbourg, France</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Strasbourg, France</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 incidence of stone disease of the urinary tract in children is increasingly increasing&#xD;
        with a remarkable economic impact for its management.&#xD;
  &#xD;
        This incidence is variable according to race, geographic region, socio-economic status and&#xD;
        dietary habits.&#xD;
  &#xD;
        Oxalo-calcium stones are the most common but the biochemical nature of urinary stones varies&#xD;
        depending on the region where those of a phosphatic nature are characterized by a higher&#xD;
        incidence in Europe.&#xD;
  &#xD;
        The diagnosis is confirmed by imaging. The unprepared abdomen (ASP) has low diagnostic&#xD;
        accuracy. The scanner is the reference tool but remains an irradiating examination.&#xD;
  &#xD;
        Risk factors for disease recurrence include primarily the presence of an underlying urinary&#xD;
        metabolic abnormality and young age. Urinary metabolic abnormalities vary from one study to&#xD;
        another.&#xD;
  &#xD;
        The understanding of lithogenesis, its evaluation as well as the therapeutic options is&#xD;
        essential for adequate and adapted management in the pediatric population.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 23, 2023</start_date>
    <completion_date type="Anticipated">August 23, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 23, 2024</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Study of the modalities of the therapeutic management of children with urinary stones, retrospective description of the evolutionary aspects and the risk factors associated with recurrence.</measure>
      <time_frame>Files analysed retrospectively from January 01, 2010 to December 31, 2022 will be examined</time_frame>
      <description>This study is retrospective on already existing data</description>
    </primary_outcome>
    <enrollment type="Anticipated">140</enrollment>
    <condition>Urinary Lithiasis</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients aged less than 18 years presenting with lithiasis of the urinary tree in one of&#xD;
          the two departments concerned between 01/01/2010 and 12/31/2022&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Patients aged less than 18 years.&#xD;
  &#xD;
            -  Both sexes.&#xD;
  &#xD;
            -  Subjects presenting with lithiasis of the urinary tree in one of the two departments&#xD;
               concerned between 01/01/2010 and 12/31/2022&#xD;
  &#xD;
            -  Subject not opposing, after information, the reuse of their data for the purposes of&#xD;
               this research.&#xD;
  &#xD;
            -  Holders of parental authority who do not object, after being informed, to the reuse of&#xD;
               their child's data for the purposes of this research.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Subject or holder of parental authority having expressed opposition to participating&#xD;
               in the study.&#xD;
  &#xD;
            -  Non-usable patient files: insufficient data.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Isabelle TALON, MD</last_name>
      <phone>33 3 88 12 72 96</phone>
      <email>Isabelle.TALON@chru-strasbourg.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Service de Pédiatrie 1 - CHU de Strasbourg - France</name>
        <address>
          <city>Strasbourg</city>
          <zip>67091</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Isabelle TALON, MD</last_name>
        <phone>33 3 88 12 72 96</phone>
        <email>Isabelle.TALON@chru-strasbourg.fr</email>
      </contact>
      <investigator>
        <last_name>Isabelle TALON, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Kamal EL HAISSOUFI, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Urinary Lithiasis</keyword>
    <keyword>Stone disease</keyword>
    <keyword>Urolithiasis</keyword>
    <keyword>Urinary Calculi</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urolithiasis</mesh_term>
      <mesh_term>Urinary Calculi</mesh_term>
      <mesh_term>Lithiasis</mesh_term>
    </condition_browse>
    <!-- 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/NCT06032364
  org study id: 9020
  nct id: NCT06032364
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The incidence of stone disease of the urinary tract in children is increasingly increasing
        with a remarkable economic impact for its management.
  
        This incidence is variable according to race, geographic region, socio-economic status and
        dietary habits.
  
        Oxalo-calcium stones are the most common but the biochemical nature of urinary stones varies
        depending on the region where those of a phosphatic nature are characterized by a higher
        incidence in Europe.
  
        The diagnosis is confirmed by imaging. The unprepared abdomen (ASP) has low diagnostic
        accuracy. The scanner is the reference tool but remains an irradiating examination.
  
        Risk factors for disease recurrence include primarily the presence of an underlying urinary
        metabolic abnormality and young age. Urinary metabolic abnormalities vary from one study to
        another.
  
        The understanding of lithogenesis, its evaluation as well as the therapeutic options is
        essential for adequate and adapted management in the pediatric population.
  observational model: Case-Only
  time perspective: Retrospective
  measure: Study of the modalities of the therapeutic management of children with urinary stones, retrospective description of the evolutionary aspects and the risk factors associated with recurrence.
  time frame: Files analysed retrospectively from January 01, 2010 to December 31, 2022 will be examined
  description: This study is retrospective on already existing data
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Year
  maximum age: 17 Years
  healthy volunteers: No
  last name: Isabelle TALON, MD
  phone: 33 3 88 12 72 96
  email: Isabelle.TALON@chru-strasbourg.fr
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Urolithiasis
  mesh term: Urinary Calculi
  mesh term: Lithiasis