<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/NCT04502498</url>
  </required_header>
  <id_info>
    <org_study_id>Cairo University Hospital</org_study_id>
    <nct_id>NCT04502498</nct_id>
  </id_info>
  <brief_title>Preoperative Subclinical DVT Screening in Locally Advanced Bladder Cancer Patients Candidate for Radical Cystectomy.</brief_title>
  <official_title>Preoperative Detection of Subclinical Lower Limb Deep Venous Thrombosis in Locally Advanced Bladder Cancer Patients Candidate for Radical Cystectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kasr El Aini Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kasr El Aini Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Preoperative subclinical DVT screening in locally advanced bladder cancer patients candidate&#xD;
      for radical cystectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      60 patient with local advanced bladder cancer are subjected to preoperative lower limb duplex&#xD;
      within 1 week preoperative to radical cystectomy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2020</start_date>
  <completion_date type="Anticipated">October 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Preoperative subclinical DVT</measure>
    <time_frame>6 months</time_frame>
    <description>Asymptomatic patients candidate for radical cystectomy</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Bladder Cancer Patients Candidate for Radical Cystectomy</condition>
  <arm_group>
    <arm_group_label>60 patients with local advanced bladder cancer</arm_group_label>
    <description>Local advanced bladder cancer patients candidate for radical cystectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Lower limb duplex &amp; doppler</intervention_name>
    <description>Lower limb duplex and doppler one week before radical cystectomy</description>
    <arm_group_label>60 patients with local advanced bladder cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Locally advanced Bladder cancer patients candidate for radical cystectomy and with no&#xD;
        symptoms of DVT&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  any age&#xD;
&#xD;
          -  Any sex&#xD;
&#xD;
          -  Muscle invasive bladder cancer local advanced patients candidate for radical&#xD;
             cystectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unfit patients&#xD;
&#xD;
          -  any contraindication for surgery&#xD;
&#xD;
          -  obese&#xD;
&#xD;
          -  coagulopathy&#xD;
&#xD;
          -  bedridden&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
    <investigator_full_name>Samer Morsy</investigator_full_name>
    <investigator_title>Urology lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</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/NCT04502498
org study id: Cairo University Hospital
nct id: NCT04502498
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Preoperative subclinical DVT screening in locally advanced bladder cancer patients candidate
      for radical cystectomy.
60 patient with local advanced bladder cancer are subjected to preoperative lower limb duplex
      within 1 week preoperative to radical cystectomy
observational model: Other
time perspective: Prospective
measure: Preoperative subclinical DVT
time frame: 6 months
description: Asymptomatic patients candidate for radical cystectomy
arm group label: 60 patients with local advanced bladder cancer
description: Local advanced bladder cancer patients candidate for radical cystectomy
intervention type: Diagnostic Test
intervention name: Lower limb duplex & doppler
description: Lower limb duplex and doppler one week before radical cystectomy
arm group label: 60 patients with local advanced bladder cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Kasr El Aini Hospital
investigator full name: Samer Morsy
investigator title: Urology lecturer
mesh term: Urinary Bladder Neoplasms