<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/NCT04506723</url>
  </required_header>
  <id_info>
    <org_study_id>Stone-CL-01</org_study_id>
    <nct_id>NCT04506723</nct_id>
  </id_info>
  <brief_title>Comparison of Morphological and Radiological Data in Patients With Urolithiasis</brief_title>
  <official_title>Comparison of the Morphological Picture of the Renal Parenchyma With the Results of Mathematical Analysis of Intrarenal Transport of Contrast Medium in Computed Tomography in Patients With Urolithiasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>I.M. Sechenov First Moscow State Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>I.M. Sechenov First Moscow State Medical University</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 aim of the study was to compare the ultrastructural changes in the renal parenchyma with&#xD;
      the results of postprocessing CT analysis with contrast enhancement in patients with&#xD;
      urolithiasis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 30, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate the features of interrenal transport of contrast agent and the structural state of the renal tissue</measure>
    <time_frame>1 month</time_frame>
    <description>The data of 3D analysis of CT of the kidneys in patients with urolithiasis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To assess the features of the morphological structure of glomeruli, tubules, perivascular and interstitial spaces of renal tissue in patients with urolithiasis</measure>
    <time_frame>2 weeks</time_frame>
    <description>The assessment will be based on intraoperative biopsy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Urolithiasis</condition>
  <arm_group>
    <arm_group_label>Patients with urolithiasis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with confirmed urolithiasis who is assigned to PCNL.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients without urolithiasis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with renal tumor without urolithiasis in history who is assigned to partial or radical nephrectomy due to renal tumor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous Nephrolithotomy</intervention_name>
    <description>PCNL will be carried out in accordance with the standards and capabilities of the medical center. After the procedure pathomorphological data of the renal parenchyma will be assessed</description>
    <arm_group_label>Patients with urolithiasis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Partial nephrectomy</intervention_name>
    <description>Partial nephrectomy will be carried out in accordance with the standards and capabilities of the medical center. After the procedure pathomorphological data of the renal parenchyma will be assessed</description>
    <arm_group_label>Patients without urolithiasis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radical nephrectomy</intervention_name>
    <description>Nephrectomy will be carried out in accordance with the standards and capabilities of the medical center. After the procedure pathomorphological data of the renal parenchyma will be assessed</description>
    <arm_group_label>Patients without urolithiasis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for experimental group:&#xD;
&#xD;
          1. Men and women &gt;18 years and &lt;45 years old;&#xD;
&#xD;
          2. Established diagnosis of urolithiasis that does not interfere with the processes of&#xD;
             urodynamics (there is no expansion of the overlying urinary tract);&#xD;
&#xD;
          3. Planned surgery - percutaneous nephrolithotripsy;&#xD;
&#xD;
          4. Stone size up to 20 mm., Patients with multiple small two-sided stones;&#xD;
&#xD;
          5. Patients with CT of the kidneys with contrast enhancement performed according to the&#xD;
             required protocol.&#xD;
&#xD;
        Exclusion Criteria for experimental group:&#xD;
&#xD;
          1. Age &lt; 18 years old or ASA&gt; 3;&#xD;
&#xD;
          2. With single kidney;&#xD;
&#xD;
          3. Patients with coral stones;&#xD;
&#xD;
          4. The presence of concomitant systemic pathology (DM, AH), as well as kidney disease&#xD;
             (glomerulonephritis), which can change the state of the renal parenchyma;&#xD;
&#xD;
          5. A history of injuries and surgical interventions on the kidneys, urinary tract, renal&#xD;
             vessels;&#xD;
&#xD;
          6. Taking nephrotropic drugs;&#xD;
&#xD;
          7. Systemic intake of nephrotoxic drugs;&#xD;
&#xD;
          8. Severe general somatic condition, making the operation impossible;&#xD;
&#xD;
          9. Pregnancy.&#xD;
&#xD;
        Inclusion Criteria for control group:&#xD;
&#xD;
          1. Men and women &gt;18 years and &lt;45 years old;&#xD;
&#xD;
          2. Absence of urolithiasis in the patient's anamnesis and in his family history;&#xD;
&#xD;
          3. Renal tumors which have undergone partial nephrectomy or nephrectomy;&#xD;
&#xD;
          4. Patients with CT renal data with contrast enhancement, performed according to the&#xD;
             required protocol.&#xD;
&#xD;
        Exclusion Criteria for control group:&#xD;
&#xD;
          1. Urolithiasis in anamnesis;&#xD;
&#xD;
          2. A history of trauma and surgical interventions on the kidneys, urinary tract, renal&#xD;
             vessels;&#xD;
&#xD;
          3. Intercurrent background;&#xD;
&#xD;
          4. Non-informative biopsy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dmitry Enikeev, M.D., Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Sechenov University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dmitry Fiev, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sechenov University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dmitry Fiev, M.D., Ph.D.</last_name>
    <phone>+79265690949</phone>
    <email>fiev@mail.ru</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institute for Urology and Reproductive Health, Sechenov University.</name>
      <address>
        <city>Moscow</city>
        <zip>119991</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dmitry Enikeev, MD</last_name>
      <phone>+7 925 517 79 26</phone>
      <email>enikeev-dv@1msmu.ru</email>
    </contact>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>July 21, 2021</last_update_submitted>
  <last_update_submitted_qc>July 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>I.M. Sechenov First Moscow State Medical University</investigator_affiliation>
    <investigator_full_name>Dmitry Enikeev, MD, PhD</investigator_full_name>
    <investigator_title>Deputy Director for Research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urolithiasis</mesh_term>
    <mesh_term>Urinary Calculi</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/NCT04506723
org study id: Stone-CL-01
nct id: NCT04506723
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study was to compare the ultrastructural changes in the renal parenchyma with
      the results of postprocessing CT analysis with contrast enhancement in patients with
      urolithiasis.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: To evaluate the features of interrenal transport of contrast agent and the structural state of the renal tissue
time frame: 1 month
description: The data of 3D analysis of CT of the kidneys in patients with urolithiasis
measure: To assess the features of the morphological structure of glomeruli, tubules, perivascular and interstitial spaces of renal tissue in patients with urolithiasis
time frame: 2 weeks
description: The assessment will be based on intraoperative biopsy
arm group label: Patients with urolithiasis
arm group type: Experimental
description: Patients with confirmed urolithiasis who is assigned to PCNL.
arm group label: Patients without urolithiasis
arm group type: Active Comparator
description: Patients with renal tumor without urolithiasis in history who is assigned to partial or radical nephrectomy due to renal tumor.
intervention type: Procedure
intervention name: Percutaneous Nephrolithotomy
description: PCNL will be carried out in accordance with the standards and capabilities of the medical center. After the procedure pathomorphological data of the renal parenchyma will be assessed
arm group label: Patients with urolithiasis
intervention type: Procedure
intervention name: Partial nephrectomy
description: Partial nephrectomy will be carried out in accordance with the standards and capabilities of the medical center. After the procedure pathomorphological data of the renal parenchyma will be assessed
arm group label: Patients without urolithiasis
intervention type: Procedure
intervention name: Radical nephrectomy
description: Nephrectomy will be carried out in accordance with the standards and capabilities of the medical center. After the procedure pathomorphological data of the renal parenchyma will be assessed
arm group label: Patients without urolithiasis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Dmitry Enikeev, M.D., Ph.D.
role: Study Director
affiliation: Sechenov University
last name: Dmitry Fiev, M.D., Ph.D.
role: Principal Investigator
affiliation: Sechenov University
last name: Dmitry Fiev, M.D., Ph.D.
phone: +79265690949
email: fiev@mail.ru
facility: 
status: Recruiting
contact: 
country: Russian Federation
responsible party type: Principal Investigator
investigator affiliation: I.M. Sechenov First Moscow State Medical University
investigator full name: Dmitry Enikeev, MD, PhD
investigator title: Deputy Director for Research
mesh term: Urolithiasis
mesh term: Urinary Calculi
sharing ipd: No