<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/NCT03789682</url>
  </required_header>
  <id_info>
    <org_study_id>FUSCC-URO1201-2018-1</org_study_id>
    <nct_id>NCT03789682</nct_id>
  </id_info>
  <brief_title>CD155 in Bladder Cancer</brief_title>
  <official_title>Predictive Value of CD155 for Survival and Effectiveness of Chemotherapy in Patients With Muscle Invasive Bladder Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research is designed to investigate the prognostic and predictive value of CD155 in&#xD;
      muscle invasive bladder cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">January 1, 2028</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2023</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>Recurrence free survival</measure>
    <time_frame>2018.1.1-2023.12.31</time_frame>
    <description>Time to recurrence or metastasis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>2018.1.1-2028.1.1</time_frame>
    <description>Time to death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Benefit from neoadjuvant chemotherapy</measure>
    <time_frame>2018.1.1-2028.1.1</time_frame>
    <description>response to neoadjuvant chemotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Benefit from adjuvant chemotherapy</measure>
    <time_frame>2018.1.1-2028.1.1</time_frame>
    <description>Survival analysis grouped by adjuvant chemotherapy</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>FUSCC cystectomy cohort</arm_group_label>
    <description>patients underwent cystectomy in Fudan University Shanghai Cancer Center</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adjuvant chemotherapy</intervention_name>
    <description>adjuvant chemotherapy using Gemcitabine plus Cisplatin</description>
    <arm_group_label>FUSCC cystectomy cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with non-metastatic muscle invasive bladder cancer underwent cystectomy in Fudan&#xD;
        University Shanghai Cancer Center is included&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with non-metastatic muscle invasive bladder cancer&#xD;
&#xD;
          -  pathology confirmed urothelial carcinoma&#xD;
&#xD;
          -  underwent cystectomy and pelvic lymph node dissection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not enough tissue for immunohistochemistry&#xD;
&#xD;
          -  patients with a second neoplasm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dai Bo, MD</last_name>
      <phone>+86-21 64175590</phone>
      <email>16211230020@fudan.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Dai Bo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>February 3, 2020</last_update_submitted>
  <last_update_submitted_qc>February 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Bo Dai</investigator_full_name>
    <investigator_title>Department of Urology</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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03789682
org study id: FUSCC-URO1201-2018-1
nct id: NCT03789682
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This research is designed to investigate the prognostic and predictive value of CD155 in
      muscle invasive bladder cancer.
observational model: Cohort
time perspective: Prospective
measure: Recurrence free survival
time frame: 2018.1.1-2023.12.31
description: Time to recurrence or metastasis
measure: Overall survival
time frame: 2018.1.1-2028.1.1
description: Time to death
measure: Benefit from neoadjuvant chemotherapy
time frame: 2018.1.1-2028.1.1
description: response to neoadjuvant chemotherapy
measure: Benefit from adjuvant chemotherapy
time frame: 2018.1.1-2028.1.1
description: Survival analysis grouped by adjuvant chemotherapy
arm group label: FUSCC cystectomy cohort
description: patients underwent cystectomy in Fudan University Shanghai Cancer Center
intervention type: Drug
intervention name: Adjuvant chemotherapy
description: adjuvant chemotherapy using Gemcitabine plus Cisplatin
arm group label: FUSCC cystectomy cohort
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Bo Dai
investigator title: Department of Urology
mesh term: Urinary Bladder Neoplasms
sharing ipd: Undecided