<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/NCT04506671</url>
  </required_header>
  <id_info>
    <org_study_id>CA_vs_PN</org_study_id>
    <nct_id>NCT04506671</nct_id>
  </id_info>
  <brief_title>Percutaneous Cryoablation Versus Partial Nephrectomy for T1b Renal Tumor</brief_title>
  <official_title>A Prospective, Non-randomized, in Parallel Groups Study Evaluating the Efficacy and Safety of Percutaneous Cryoablation and Partial Nephrectomy in Localized T1b Renal Tumor</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 our study is to assess the long-term oncological and functional outcomes of&#xD;
      cryoablation for T1b renal tumors, as well as such important parameters as the patient's&#xD;
      quality of life after treatment, and to compare the results with those after partial&#xD;
      nephrectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 22, 2020</start_date>
  <completion_date type="Anticipated">June 22, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 22, 2025</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Local recurrence</measure>
    <time_frame>5 years</time_frame>
    <description>Local recurrance will be evaluated with CT after 6 months, a year, then annually - up to 5 years after the treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Metastatic progression</measure>
    <time_frame>5 years</time_frame>
    <description>Presence of metastases will be evaluated with CT after 6 months, a year, then annually - up to 5 years after the treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30)</measure>
    <time_frame>5 years</time_frame>
    <description>Quality of life will be assessed using scales EORTC QLQ C-30, ranging from 1 to 100, where higher score indicating a better Quality of Life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal function</measure>
    <time_frame>5 years</time_frame>
    <description>Renal function will be evaluated with eGFR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of adverse events</measure>
    <time_frame>3 months</time_frame>
    <description>Rate of intra- and postoperative adverse events will be assessed according to Clavien-Dindo grade system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood loss</measure>
    <time_frame>12 months</time_frame>
    <description>Pre- and postoperative Hb level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>1 month</time_frame>
    <description>Number of days spent in hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain score</measure>
    <time_frame>5 years</time_frame>
    <description>Pain score will be assessed using visual analogue scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">142</enrollment>
  <condition>Renal Tumor</condition>
  <arm_group>
    <arm_group_label>Cryoablation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with T1b renal tumor and ECOQ&gt;20</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Partial nephrectomy group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with T1b renal tumor</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Renal biopsy</intervention_name>
    <description>Renal biopsy will be performed prior to the cryoablation on the basis of the center and according to the current protocols</description>
    <arm_group_label>Cryoablation group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cryoablation</intervention_name>
    <description>Cryoablation under CT guidance will be performed on the basis of the center and according to the current protocols</description>
    <arm_group_label>Cryoablation group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Partial nephrectomy</intervention_name>
    <description>Partial nephrectomy will be performed on the basis of the center and according to the current protocols</description>
    <arm_group_label>Partial nephrectomy group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        •CT-confirmed renal mass &gt; 4 to 7 cm (T1b)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple renal tumors;&#xD;
&#xD;
          -  Recurrence of renal tumor;&#xD;
&#xD;
          -  Intolerance to iodine-containing contrast agents;&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  Patients with Bosniak 4 cysts&#xD;
&#xD;
          -  Presence of other oncological diseases;&#xD;
&#xD;
          -  Impossibility of organ-preserving treatment due to the proximity of the tumor to the&#xD;
             vessels or the calyx-pelvic system&#xD;
&#xD;
          -  Absence of malignant pathology based on prior biopsy.&#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>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, M.D., Ph.D</last_name>
      <phone>+7 9670897154</phone>
      <email>enikeev-dv@1msmu.ru</email>
    </contact>
    <contact_backup>
      <last_name>Mark Taratkin, MD</last_name>
      <phone>+7 9670897154</phone>
      <email>marktaratkin@gmail.com</email>
    </contact_backup>
  </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 7, 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 28, 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>
  <keyword>Cryoablation</keyword>
  <keyword>Renal cancer</keyword>
  <keyword>Partial nephrectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Neoplasms</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/NCT04506671
org study id: CA_vs_PN
nct id: NCT04506671
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of our study is to assess the long-term oncological and functional outcomes of
      cryoablation for T1b renal tumors, as well as such important parameters as the patient's
      quality of life after treatment, and to compare the results with those after partial
      nephrectomy.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Local recurrence
time frame: 5 years
description: Local recurrance will be evaluated with CT after 6 months, a year, then annually - up to 5 years after the treatment
measure: Metastatic progression
time frame: 5 years
description: Presence of metastases will be evaluated with CT after 6 months, a year, then annually - up to 5 years after the treatment
measure: Quality of life assessment: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30)
time frame: 5 years
description: Quality of life will be assessed using scales EORTC QLQ C-30, ranging from 1 to 100, where higher score indicating a better Quality of Life
measure: Renal function
time frame: 5 years
description: Renal function will be evaluated with eGFR
measure: Rate of adverse events
time frame: 3 months
description: Rate of intra- and postoperative adverse events will be assessed according to Clavien-Dindo grade system
measure: Blood loss
time frame: 12 months
description: Pre- and postoperative Hb level
measure: Length of hospital stay
time frame: 1 month
description: Number of days spent in hospital
measure: Pain score
time frame: 5 years
description: Pain score will be assessed using visual analogue scale
arm group label: Cryoablation group
arm group type: Experimental
description: Patients with T1b renal tumor and ECOQ>20
arm group label: Partial nephrectomy group
arm group type: Active Comparator
description: Patients with T1b renal tumor
intervention type: Procedure
intervention name: Renal biopsy
description: Renal biopsy will be performed prior to the cryoablation on the basis of the center and according to the current protocols
arm group label: Cryoablation group
intervention type: Procedure
intervention name: Cryoablation
description: Cryoablation under CT guidance will be performed on the basis of the center and according to the current protocols
arm group label: Cryoablation group
intervention type: Procedure
intervention name: Partial nephrectomy
description: Partial nephrectomy will be performed on the basis of the center and according to the current protocols
arm group label: Partial nephrectomy group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
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: Kidney Neoplasms
sharing ipd: No