<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/NCT03238547</url>
  </required_header>
  <id_info>
    <org_study_id>URiSCAN_SNU_01</org_study_id>
    <nct_id>NCT03238547</nct_id>
  </id_info>
  <brief_title>Screening of Microalbuminuria Using a Semi-quantitative UACR Test</brief_title>
  <official_title>Accuracy of a Semi-quantitative Urine Albumin-to-creatinine Ratio Test as a Screening Tool for Microalbuminuria in Patients With Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Microalbuminuria is an important biomarker for the development of diabetic nephropathy and&#xD;
      cardiovascular complications. Since microalbuminuria is not easily detected on routine&#xD;
      urinalysis, current guidelines recommend measuring spot urine albumin-to-creatinine ratio&#xD;
      (uACR) annually in a patient with diabetes mellitus. While the standard method is&#xD;
      quantitative measurement using turbidimetric immunoassay, it requires high cost and special&#xD;
      laboratory equipment. This may be a hurdle that prevents screening for microalbuminuria in&#xD;
      many patients with diabetes. Therefore, a semi-quantitative uACR test, which is rapid and&#xD;
      inexpensive, could be used as a substitute to the current standard quantitative measurement.&#xD;
      The investigators aimed to assess the diagnostic accuracy of a semi-quantitative urine&#xD;
      albumin-to-creatinine ratio test, URiSCAN 2ACR, as a screening tool for microalbuminuria in&#xD;
      patients with diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>18 Months</target_duration>
  <primary_outcome>
    <measure>Diagnostic Sensitivity and Specificity</measure>
    <time_frame>through study completion, an average of 18 months</time_frame>
    <description>Diagnostic Sensitivity and Specificity of URiSCAN 2ACR compared with standard method</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1000</enrollment>
  <condition>Diabetes</condition>
  <condition>Microalbuminuria</condition>
  <arm_group>
    <arm_group_label>diabetes</arm_group_label>
    <description>Diabetes patients with normal renal function and normal urinalysis</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>semi-quantitative urine albumin-to-creatinine ratio test</intervention_name>
    <description>measurement of urine albumin-to-creatinine ratio using URiSCAN 2ACR, a semi-quantitative urine albumin-to-creatinine ratio test</description>
    <arm_group_label>diabetes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>standard quantitative spot urine albumin-to-creatinine ratio</intervention_name>
    <description>measurement of urine albumin-to-creatinine ratio using a standard turbidimetric immunoassay</description>
    <arm_group_label>diabetes</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        diabetic patients following Seoul National University Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  microscopic hematuria&#xD;
&#xD;
          -  pyuria&#xD;
&#xD;
          -  urinary cast&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>March 24, 2020</last_update_submitted>
  <last_update_submitted_qc>March 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Dong Ki Kim</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Albuminuria</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03238547
org study id: URiSCAN_SNU_01
nct id: NCT03238547
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
Microalbuminuria is an important biomarker for the development of diabetic nephropathy and
      cardiovascular complications. Since microalbuminuria is not easily detected on routine
      urinalysis, current guidelines recommend measuring spot urine albumin-to-creatinine ratio
      (uACR) annually in a patient with diabetes mellitus. While the standard method is
      quantitative measurement using turbidimetric immunoassay, it requires high cost and special
      laboratory equipment. This may be a hurdle that prevents screening for microalbuminuria in
      many patients with diabetes. Therefore, a semi-quantitative uACR test, which is rapid and
      inexpensive, could be used as a substitute to the current standard quantitative measurement.
      The investigators aimed to assess the diagnostic accuracy of a semi-quantitative urine
      albumin-to-creatinine ratio test, URiSCAN 2ACR, as a screening tool for microalbuminuria in
      patients with diabetes.
observational model: Other
time perspective: Cross-Sectional
measure: Diagnostic Sensitivity and Specificity
time frame: through study completion, an average of 18 months
description: Diagnostic Sensitivity and Specificity of URiSCAN 2ACR compared with standard method
arm group label: diabetes
description: Diabetes patients with normal renal function and normal urinalysis
intervention type: Diagnostic Test
intervention name: semi-quantitative urine albumin-to-creatinine ratio test
description: measurement of urine albumin-to-creatinine ratio using URiSCAN 2ACR, a semi-quantitative urine albumin-to-creatinine ratio test
arm group label: diabetes
intervention type: Diagnostic Test
intervention name: standard quantitative spot urine albumin-to-creatinine ratio
description: measurement of urine albumin-to-creatinine ratio using a standard turbidimetric immunoassay
arm group label: diabetes
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Dong Ki Kim
investigator title: Prof.
mesh term: Albuminuria
sharing ipd: No