xml: <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/NCT05982561</url>
    </required_header>
    <id_info>
      <org_study_id>EIG 2023-02</org_study_id>
      <nct_id>NCT05982561</nct_id>
    </id_info>
    <brief_title>Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer</brief_title>
    <official_title>Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Early is Good Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Early is Good Inc.</source>
    <brief_summary>
      <textblock>
        BCDx is a urine-based multi-omic assay for early cancer recurrence detection in patients with&#xD;
        a history of bladder cancer. This prospective, blinded study evaluates its efficacy in&#xD;
        detecting recurrent NMIBC, offering a noninvasive monitoring solution.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        BCDx is a urine-based multi-omic/multiplex molecular assay offers a promising solution for&#xD;
        detecting cancer recurrence. It is intended for use as a noninvasive method for monitoring&#xD;
        for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with&#xD;
        bladder cancer. This is a, multicenter, prospective, blinded study to evaluate the efficacy&#xD;
        (sensitivity and specificity) of a novel multi-omics test for the detection of recurrent&#xD;
        NMIBC in patients with a history of bladder cancer undergoing surveillance.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 26, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2025</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>Sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of BCDx (the proportion of negatives that are correctly identified as such by the gold standard)</measure>
      <time_frame>Participants' urine samples will be collected before cystoscopy and analyzed using the BCDx test within 6 months to establish its overall performance characteristics.</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Bladder Cancer</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients undergoing cystoscopic surveillance for non-muscle invasive bladder cancer (NMIBC)&#xD;
          follow-up.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients 22 Years and older&#xD;
  &#xD;
            -  Patients who have been diagnosed with incident or recurrent NMIBC within the past 2&#xD;
               years and undergoing standard of care/routine monitoring cystoscopy.&#xD;
  &#xD;
            -  Patients who are able to provide legally effective informed consent.&#xD;
  &#xD;
            -  Patients who are able to provide minimum 40mL of voided urine.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients planning to undergo radical cystectomy or chemotherapy-radiation for&#xD;
               Urothelial Cell Carcinoma.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Thakshila Liyanage, PhD</last_name>
      <phone>(317) 941-6953</phone>
      <email>thakshila@earlyisgood.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Arkansas Urology Research Center</name>
        <address>
          <city>Little Rock</city>
          <state>Arkansas</state>
          <zip>72211</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marotte,</last_name>
      </contact>
      <investigator>
        <last_name>Jeff Marotte, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Indiana University School of Medicine</name>
        <address>
          <city>Indianapolis</city>
          <state>Indiana</state>
          <zip>46202</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Hristos Kaimakliotis, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Washington University</name>
        <address>
          <city>Saint Louis</city>
          <state>Missouri</state>
          <zip>63130</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Eric Kim, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</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>Non-Muscle Invasive Bladder Neoplasms</mesh_term>
      <mesh_term>Recurrence</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05982561
  org study id: EIG 2023-02
  nct id: NCT05982561
  lead sponsor: 
  BCDx is a urine-based multi-omic assay for early cancer recurrence detection in patients with
        a history of bladder cancer. This prospective, blinded study evaluates its efficacy in
        detecting recurrent NMIBC, offering a noninvasive monitoring solution.
  BCDx is a urine-based multi-omic/multiplex molecular assay offers a promising solution for
        detecting cancer recurrence. It is intended for use as a noninvasive method for monitoring
        for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with
        bladder cancer. This is a, multicenter, prospective, blinded study to evaluate the efficacy
        (sensitivity and specificity) of a novel multi-omics test for the detection of recurrent
        NMIBC in patients with a history of bladder cancer undergoing surveillance.
  observational model: Cohort
  time perspective: Prospective
  measure: Sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) of BCDx (the proportion of negatives that are correctly identified as such by the gold standard)
  time frame: Participants' urine samples will be collected before cystoscopy and analyzed using the BCDx test within 6 months to establish its overall performance characteristics.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Thakshila Liyanage, PhD
  phone: (317) 941-6953
  email: thakshila@earlyisgood.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Urinary Bladder Neoplasms
  mesh term: Non-Muscle Invasive Bladder Neoplasms
  mesh term: Recurrence