<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/NCT03256877</url>
  </required_header>
  <id_info>
    <org_study_id>R2006</org_study_id>
    <nct_id>NCT03256877</nct_id>
  </id_info>
  <brief_title>Detecting Transitional Cell Carcinoma From Haematuria</brief_title>
  <acronym>TransTuFo</acronym>
  <official_title>Detecting Transitional Cell Carcinoma From Haematuria: A Study of Urinary Tissue Factor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hull University Teaching Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>C-Term Diagnostics Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hull York Medical School</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hull University Teaching Hospitals NHS Trust</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>
      To validate ELISAs for the detection of urinary tissue factor (TF) in patients suspected of&#xD;
      having bladder cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The effective diagnosis of transitional cell carcinoma (TCC), the most common form of bladder&#xD;
      cancer, is often quite challenging, due to a lack of disease-specific symptoms. Detecting TCC&#xD;
      early is crucial to increase the chances of a cure. Cystoscopy, which is currently the&#xD;
      standard test used for urothelial cancer diagnosis, is an invasive and relatively expensive&#xD;
      procedure but, while several potential markers in urine have been studied with the goal of&#xD;
      replacing cystoscopy, no urinary marker alone or in combination with others has shown&#xD;
      sufficient accuracy.&#xD;
&#xD;
      In this study, levels of tissue factor (TF) isoforms will be measured by ELISA in urine&#xD;
      samples collected from patients referred to the haematuria clinic with visible or microscopic&#xD;
      haematuria. These values will be linked to the subsequent diagnosis of each patient, and used&#xD;
      to assess the accuracy of the ELISAs in detecting TCC when compared to standard cystoscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 18, 2016</start_date>
  <completion_date type="Actual">May 16, 2019</completion_date>
  <primary_completion_date type="Actual">May 28, 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>Specificity and sensitivity of the ELISAs when compared to standard cystoscopy.</measure>
    <time_frame>Outcome measure will be assessed by 6 months after trial completion.</time_frame>
    <description>To examine the specificity and sensitivity of the ELISAs, compared to cystoscopy, in urine samples from patients presenting with gross or microscopic haematuria. The assays will provide measurements of the TF isoform concentrations present in patient urine samples, and the information on a subsequent diagnosis (or non-diagnosis) of a urothelial cancer will be obtained through reference to medical records.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Positive and negative predictive values of the ELISAs when compared to standard cystoscopy.</measure>
    <time_frame>Outcome measure will be assessed by 6 months after trial completion.</time_frame>
    <description>To determine the positive and negative predictive values of the ELISAs, compared to cystoscopy, in urine samples from patients presenting with gross or microscopic haematuria.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">750</enrollment>
  <condition>Transitional Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>All participants</arm_group_label>
    <description>Patients with haematuria.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urine samples.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Study participants will be recruited from all patients referred to the haematuria clinic&#xD;
        due to gross (visible) haematuria or findings on routine urinalysis suggestive of&#xD;
        microscopic haematuria. These patients will be undergoing routine investigative cystoscopy&#xD;
        on suspicion of urothelial cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Capable of giving written informed consent&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Referral to haematuria clinic (gross or microscopic haematuria)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide written informed consent&#xD;
&#xD;
          -  Previous radiotherapy to the bladder (e.g. prostate cancer)&#xD;
&#xD;
          -  Active urinary tract infection (Patients may be re-approached at later opportunity&#xD;
             when urinary infection is cleared and haematuria persists)&#xD;
&#xD;
          -  Current or planned treatment with neoadjuvant chemotherapy or radiotherapy&#xD;
&#xD;
          -  Other known malignant condition, either active or in complete remission ≤5 years&#xD;
&#xD;
          -  HIV, hepatitis C, or any other known communicable disease&#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>Castle Hill Hospital</name>
      <address>
        <city>Hull</city>
        <zip>HU16 5JQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>July 26, 2019</last_update_submitted>
  <last_update_submitted_qc>July 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2019</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>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Transitional Cell</mesh_term>
    <mesh_term>Hematuria</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/NCT03256877
org study id: R2006
nct id: NCT03256877
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To validate ELISAs for the detection of urinary tissue factor (TF) in patients suspected of
      having bladder cancer.
The effective diagnosis of transitional cell carcinoma (TCC), the most common form of bladder
      cancer, is often quite challenging, due to a lack of disease-specific symptoms. Detecting TCC
      early is crucial to increase the chances of a cure. Cystoscopy, which is currently the
      standard test used for urothelial cancer diagnosis, is an invasive and relatively expensive
      procedure but, while several potential markers in urine have been studied with the goal of
      replacing cystoscopy, no urinary marker alone or in combination with others has shown
      sufficient accuracy.

      In this study, levels of tissue factor (TF) isoforms will be measured by ELISA in urine
      samples collected from patients referred to the haematuria clinic with visible or microscopic
      haematuria. These values will be linked to the subsequent diagnosis of each patient, and used
      to assess the accuracy of the ELISAs in detecting TCC when compared to standard cystoscopy.
observational model: Cohort
time perspective: Prospective
measure: Specificity and sensitivity of the ELISAs when compared to standard cystoscopy.
time frame: Outcome measure will be assessed by 6 months after trial completion.
description: To examine the specificity and sensitivity of the ELISAs, compared to cystoscopy, in urine samples from patients presenting with gross or microscopic haematuria. The assays will provide measurements of the TF isoform concentrations present in patient urine samples, and the information on a subsequent diagnosis (or non-diagnosis) of a urothelial cancer will be obtained through reference to medical records.
measure: Positive and negative predictive values of the ELISAs when compared to standard cystoscopy.
time frame: Outcome measure will be assessed by 6 months after trial completion.
description: To determine the positive and negative predictive values of the ELISAs, compared to cystoscopy, in urine samples from patients presenting with gross or microscopic haematuria.
arm group label: All participants
description: Patients with haematuria.
Urine samples.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Transitional Cell
mesh term: Hematuria
sharing ipd: No