<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/NCT02246738</url>
  </required_header>
  <id_info>
    <org_study_id>UPCC 07814</org_study_id>
    <nct_id>NCT02246738</nct_id>
  </id_info>
  <brief_title>Initial Evaluation of a Telomerase-based Circulating Tumor Cell Assay in Bladder Cancer Cohorts</brief_title>
  <official_title>Initial Evaluation of a Telomerase-based Circulating Tumor Cell Assay in Bladder Cancer Cohorts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abramson Cancer Center at Penn Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abramson Cancer Center at Penn Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purposes are to determine whether various cohorts of bladder cancer patients have detectable&#xD;
      tCTC's, determine it tCTC levels vary with the natural history of bladder cancer and to see&#xD;
      if tCTC's provide novel information.Study population are various cohorts of patients&#xD;
      diangosed with urothelial carcinoma of the bladder.Procedures include a venous blood draw, up&#xD;
      to two times, over a 6 month period for collection of tCTC's. Up to 15 mL's of blood will be&#xD;
      collected at each blood draw.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">October 2020</completion_date>
  <primary_completion_date type="Actual">August 2018</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>Number of Adverse Events</measure>
    <time_frame>4 Years</time_frame>
  </primary_outcome>
  <number_of_groups>9</number_of_groups>
  <enrollment type="Actual">87</enrollment>
  <condition>Urothelial Carcinoma of the Bladder</condition>
  <arm_group>
    <arm_group_label>Cohort1</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 5</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 6</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 7</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 8</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 9</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood Collection</intervention_name>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_label>Cohort 3</arm_group_label>
    <arm_group_label>Cohort 4</arm_group_label>
    <arm_group_label>Cohort 5</arm_group_label>
    <arm_group_label>Cohort 6</arm_group_label>
    <arm_group_label>Cohort 7</arm_group_label>
    <arm_group_label>Cohort 8</arm_group_label>
    <arm_group_label>Cohort 9</arm_group_label>
    <arm_group_label>Cohort1</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood Collection&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Urothelial Carcinoma of the Bladder&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a.Urothelial carcinoma or mixed urothelial carcinoma arising from the bladder&#xD;
&#xD;
          -  b.Age 18 or older&#xD;
&#xD;
          -  Inclusions by cohort Cohort 1. Patients with localized muscle-invasive disease&#xD;
             (cT1,cN0, M0) at the time of initial diagnosis or who have progressed from superficial&#xD;
             disease (cT2) who have not had any systemic chemotherapy and who will be treated with&#xD;
             upfront radical cystectomy. PriorTURBT and intravesical therapies are allowed but&#xD;
             should not have been done within one week of CTC measurement. If the patient is found&#xD;
             to have no evidence of tumor (pT0) upon evaluation of the cystectomy specimen, the&#xD;
             patient will not be dropped. If the patient is found to have evidence of progression&#xD;
             by any clinical evaluation performed within 2 months of the post-treatment sample, the&#xD;
             patient will be dropped from Cohort 1 and included in Cohort 9 instead.&#xD;
&#xD;
          -  Cohort 2. Patients with localized muscle-invasive disease (cT1, cN0, M0) at the time&#xD;
             of initial diagnosis prior to definitivechemo-radiation. Prior TURBT and intravesical&#xD;
             therapies are allowed but should not have been done within one week of CTC&#xD;
             measurement. If the patient is found to have evidence of progression by anyclinical&#xD;
             evaluation performed within 2 months of the post-treatment sample, the patient will be&#xD;
             droppedfrom Cohort 2 and included in Cohort 9 instead.&#xD;
&#xD;
          -  Cohort 3. Patients with localized muscle-invasive disease (cT1, cN0, M0) at the time&#xD;
             of initial diagnosis or who have progressed from superficial disease (cT2) who have&#xD;
             not had any systemic chemotherapy and who will be treated with neoadjuvant&#xD;
             chemotherapy. Prior TURBT and intravesical therapies are allowed but should not have&#xD;
             been done within one week of CTC measurement. If the patient is found to have evidence&#xD;
             of progression by any clinical evaluation performed within 2 months of the&#xD;
             post-treatment sample, the patient will be dropped from Cohort 3 and included in&#xD;
             Cohort 9 instead.&#xD;
&#xD;
          -  Cohort 4. Patients with metastatic disease (anyT, anyN, M1) at initial presentation or&#xD;
             recurrent after definitive treatment prior to any salvage systemic chemotherapy. If&#xD;
             the patient is found to have evidence of progression by any clinical evaluation&#xD;
             performed within 2 months of the post-treatment sample, the patient will be dropped&#xD;
             from Cohort 4 and included in Cohort 9 instead.&#xD;
&#xD;
          -  Cohort 5. Patients with newly diagnosed non-muscle-invasive bladder cancer (T2) prior&#xD;
             to any intravesical therapy. If the patient is found to have evidence of progression&#xD;
             by any clinical evaluation performed within 2 months of the post-treatment sample, the&#xD;
             patient will be dropped.&#xD;
&#xD;
          -  Cohort 6. Patients with muscle-invasive bladder cancer after radical cystectomy with&#xD;
             or without peri-operative systemic chemotherapy (pT2, anyN, M0) who will be treated&#xD;
             with adjuvant radiation. If the patient is found to have evidence of progression by&#xD;
             any clinical evaluation performed within 2 months of the post-treatment sample, the&#xD;
             patient will be dropped from Cohort 6 and includedin Cohort 9 instead.&#xD;
&#xD;
          -  Cohort 7. Patients with a history of muscle invasive bladder cancer (cT1, any N,M0)&#xD;
             who have no evidence of disease at least 2 years after the date of radical cystectomy.&#xD;
             If the patient is found to have evidence of progression by any clinical evaluation&#xD;
             performed within 2 months of the post-treatment sample, the patient will be dropped&#xD;
             from Cohort 7 but may be considered for inclusion in Cohort 4.&#xD;
&#xD;
          -  Cohort 8. Patients with a history of muscle invasive bladder cancer (cT1, any N, M0)&#xD;
             who have no evidence of disease at least 2 years after the completion of definitive&#xD;
             chemo-radiation. If the patient is found to have evidence of progression by any&#xD;
             clinical evaluation performed within 2 months of the post-treatment sample, the&#xD;
             patient will be dropped from Cohort 8 but may be considered for inclusion in Cohort 4.&#xD;
&#xD;
          -  Cohort 9. Patients who were initially included in Cohorts 1-6 but were found to have&#xD;
             progression at the time of their post-treatment blood draw. Of note, patients may be&#xD;
             included in more than one cohort over time so long as inclusion and exclusion criteria&#xD;
             are met. In addition, twenty samples from normal controls without any history of&#xD;
             malignancy will be used for this study but havealready been collected as part of a&#xD;
             separate protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pure squamous or pure adenocarcinoma bladder cancer histology. This exclusion may be&#xD;
             waved at the discretion of the protocol PI. 2. Prior cancer diagnosed within 3 years&#xD;
             of enrollment other than a prior bladder, prostate, or skin cancer. This exclusion may&#xD;
             be waved at the discretion of the protocol PI.&#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>John Christodouleas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Abramson Cancer Center at Penn Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Abramson Cancer Center of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>December 8, 2020</last_update_submitted>
  <last_update_submitted_qc>December 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
    <mesh_term>Neoplastic Cells, Circulating</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/NCT02246738
org study id: UPCC 07814
nct id: NCT02246738
lead sponsor: 
has dmc: Yes
Purposes are to determine whether various cohorts of bladder cancer patients have detectable
      tCTC's, determine it tCTC levels vary with the natural history of bladder cancer and to see
      if tCTC's provide novel information.Study population are various cohorts of patients
      diangosed with urothelial carcinoma of the bladder.Procedures include a venous blood draw, up
      to two times, over a 6 month period for collection of tCTC's. Up to 15 mL's of blood will be
      collected at each blood draw.
observational model: Cohort
time perspective: Prospective
measure: Number of Adverse Events
time frame: 4 Years
arm group label: Cohort1
arm group label: Cohort 2
arm group label: Cohort 3
arm group label: Cohort 4
arm group label: Cohort 5
arm group label: Cohort 6
arm group label: Cohort 7
arm group label: Cohort 8
arm group label: Cohort 9
intervention type: Other
intervention name: Blood Collection
arm group label: Cohort 2
arm group label: Cohort 3
arm group label: Cohort 4
arm group label: Cohort 5
arm group label: Cohort 6
arm group label: Cohort 7
arm group label: Cohort 8
arm group label: Cohort 9
arm group label: Cohort1
Blood Collection
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John Christodouleas, MD
role: Principal Investigator
affiliation: Abramson Cancer Center at Penn Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms
mesh term: Neoplastic Cells, Circulating