<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/NCT01711996</url>
  </required_header>
  <id_info>
    <org_study_id>4-2012-0421</org_study_id>
    <nct_id>NCT01711996</nct_id>
  </id_info>
  <brief_title>The Correlation Between Renal Injury and Biomarkers in Pediatric Ureteropelvic Junction Obstruction Patients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be&#xD;
      related with the degree of hydronephrosis in pediatric ureteropelvic junction obstruction&#xD;
      (UPJO) patients. We are trying to analyze whether it is related with the grade of renal&#xD;
      injury in UPJO patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Difficulty in purchasing reagents and receiving consent from the subject&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2012</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 level of urinary NGAL and the degree of renal injury</measure>
    <time_frame>6 month after operation</time_frame>
    <description>Analysis of correlation between the level of urinary NGAL and the degree of renal injury</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Ureteropelvic Junction Obstruction</condition>
  <arm_group>
    <arm_group_label>UPJO</arm_group_label>
    <description>0-3 year old hydronephrosis patients without ureter dilatation who undergo pyeloplasty</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hydronephrosis</arm_group_label>
    <description>0-3 year old hydronephrosis patients without ureter dilatation who does not meet the indication of pyeloplasty</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal</arm_group_label>
    <description>0-3 year old children without hydronephrosis</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Group 1: 20 patients with UPJO undergo pyeloplasty Group 2: 20 patients with hydronephrosis&#xD;
        who does not meet the indication of pyeloplasty Group 3: 20 normal control&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        &lt;Group 1&gt;&#xD;
&#xD;
          1. 0-3 year old patients with SFU grade 2 or more hydronephrosis without ureteral&#xD;
             dilatation&#xD;
&#xD;
          2. needs pyeloplasty due to differential renal function (DRF)&lt;40%, decreased DRF by more&#xD;
             than 5%, development of urinary tract infection, development of urinary stone, and&#xD;
             development of pain related with UPJO &lt;Group 2&gt;&#xD;
&#xD;
        1. 0-3 year old patients with SFU grade 3 or 4 hydronephrosis without ureteral dilatation&#xD;
        2. doesn't meet the above criteria for the indication of pyeloplasty &lt;Group 3&gt;&#xD;
&#xD;
        1. 0-3 year old children without any abnormality of urinary tract&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        &lt;Group 1&gt;&#xD;
&#xD;
          1. patients with contralateral disease affecting DRF&#xD;
&#xD;
          2. history of previous urinary tract surgery&#xD;
&#xD;
          3. follow up loss before diuretic renogram performed at 6-12 months from operation &lt;Group&#xD;
             2, 3&gt;&#xD;
&#xD;
        1. patients with contralateral disease affecting DRF 2. history of previous urinary tract&#xD;
        surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>3 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Urology, Urological Science Institute, Yonsei University, Colleage of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>May 3, 2021</last_update_submitted>
  <last_update_submitted_qc>May 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hydronephrosis</keyword>
  <keyword>biopsy</keyword>
  <keyword>biomarker</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydronephrosis</mesh_term>
    <mesh_term>Ureteral Obstruction</mesh_term>
    <mesh_term>Multicystic Dysplastic Kidney</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/NCT01711996
org study id: 4-2012-0421
nct id: NCT01711996
lead sponsor: 
has dmc: No
Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be
      related with the degree of hydronephrosis in pediatric ureteropelvic junction obstruction
      (UPJO) patients. We are trying to analyze whether it is related with the grade of renal
      injury in UPJO patients.
observational model: Cohort
time perspective: Prospective
measure: The level of urinary NGAL and the degree of renal injury
time frame: 6 month after operation
description: Analysis of correlation between the level of urinary NGAL and the degree of renal injury
arm group label: UPJO
description: 0-3 year old hydronephrosis patients without ureter dilatation who undergo pyeloplasty
arm group label: Hydronephrosis
description: 0-3 year old hydronephrosis patients without ureter dilatation who does not meet the indication of pyeloplasty
arm group label: Normal
description: 0-3 year old children without hydronephrosis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 3 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Hydronephrosis
mesh term: Ureteral Obstruction
mesh term: Multicystic Dysplastic Kidney