<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/NCT02186925</url>
  </required_header>
  <id_info>
    <org_study_id>ren001</org_study_id>
    <nct_id>NCT02186925</nct_id>
  </id_info>
  <brief_title>A Prospective Study of Clinical Factors Affecting Disease Progression and Treatment Results of Patients With Tumors of the Prostate, Bladder and Kidney.</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Identifying clinical factors such as medication, background diseases and blood tests that&#xD;
      effect the course of disease in cancer patients can help physicians to better decide on the&#xD;
      patient's treatment plan. The study seeks to identify and analyze relevant clinical factors&#xD;
      that effect the course of the disease and the results of treatment in patients with cancers&#xD;
      of the prostate, bladder and kidney.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">August 2025</completion_date>
  <primary_completion_date type="Anticipated">August 2019</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>Progression Free Survival</measure>
    <time_frame>5 years</time_frame>
    <description>Univariate analysis will be used to assess the effects of clinical factors on progression free survival.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient overall survival</measure>
    <time_frame>5 years</time_frame>
    <description>Univariate analysis will be used to assess the effects of clinical factors on overall survival.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Kidney Cancer</condition>
  <condition>Prostate Cancer</condition>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>Bladder, Kidney and Prostate Cancer Patients</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients suffering from kidney, bladder or prostate cancer who are being treated at the&#xD;
        Meir Medical Center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with prostate, bladder or kidney cancer that are being treated at the&#xD;
             Meir Medical Center and are over 18 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under the age of 18&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daneil Kejzman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meir Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daniel Kejzman, MD</last_name>
    <phone>00972-9747-1606</phone>
    <email>daniel.kejzman@clalit.org.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Meir Medical Center</name>
      <address>
        <city>Kvar Saba</city>
        <zip>4428164</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel Kejzman, MD</last_name>
      <phone>00972-9747-1606</phone>
      <email>daniel.kejzman@clalit.org.il</email>
    </contact>
    <investigator>
      <last_name>Daniel Kejzman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>April 20, 2015</last_update_submitted>
  <last_update_submitted_qc>April 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Kidney Cancer</keyword>
  <keyword>Prostate Cancer</keyword>
  <keyword>Bladder Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
    <mesh_term>Kidney Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</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/NCT02186925
org study id: ren001
nct id: NCT02186925
lead sponsor: 
has dmc: Yes
Identifying clinical factors such as medication, background diseases and blood tests that
      effect the course of disease in cancer patients can help physicians to better decide on the
      patient's treatment plan. The study seeks to identify and analyze relevant clinical factors
      that effect the course of the disease and the results of treatment in patients with cancers
      of the prostate, bladder and kidney.
observational model: Cohort
time perspective: Prospective
measure: Progression Free Survival
time frame: 5 years
description: Univariate analysis will be used to assess the effects of clinical factors on progression free survival.
measure: Patient overall survival
time frame: 5 years
description: Univariate analysis will be used to assess the effects of clinical factors on overall survival.
arm group label: Bladder, Kidney and Prostate Cancer Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daneil Kejzman, MD
role: Principal Investigator
affiliation: Meir Medical Center
last name: Daniel Kejzman, MD
phone: 00972-9747-1606
email: daniel.kejzman@clalit.org.il
facility: 
status: Recruiting
contact: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Urinary Bladder Neoplasms
mesh term: Kidney Neoplasms
mesh term: Carcinoma, Renal Cell