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/NCT06026189</url>
    </required_header>
    <id_info>
      <org_study_id>Erasmus MC</org_study_id>
      <nct_id>NCT06026189</nct_id>
    </id_info>
    <brief_title>Safely Reduce Cystoscopic Evaluations for Hematuria Patients</brief_title>
    <acronym>SeARCH</acronym>
    <official_title>Safely Reduce Cystoscopic Evaluations for Hematuria Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Erasmus Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Erasmus Medical Center</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>
        The SeARCH-trial assess the clinical impact of a molecular urine test as a 'urine-first'&#xD;
        strategy in the diagnostic workup of patients presenting with microscopic hematuria.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Microscopic hematuria (MH) can be a sign of an underlying disease, including malignancy of&#xD;
        the urinary tract, and is reason for referral to a urology clinic. The current standard&#xD;
        diagnostic workup for MH patients includes visual inspection of the bladder by cystoscopy and&#xD;
        upper tract imaging to rule out the presence of a tumor in the urinary tract. However, the a&#xD;
        priori risk of cancer in patients with MH is only 2-5%. Consequently, 95% of MH patients&#xD;
        unnecessarily undergo invasive procedures, which are: I) uncomfortable and stressful for&#xD;
        patients, II) has a significant impact on limited available (financial) resources and III) a&#xD;
        CT scan is accompanied by exposure to ionizing radiation.&#xD;
  &#xD;
        Previously we developed a molecular urine assay to detect urinary tract cancer in hematuria&#xD;
        patients that had robust diagnostic performance; a negative predictive value &gt;99%,&#xD;
        sensitivity, and specificity &gt;90%. The SeARCH-trial evaluates the clinical impact of a urine&#xD;
        assay as a 'urine-first' strategy, meaning that only patients with an abnormal urine test&#xD;
        results undergo invasive diagnostics. In this multicenter stepped-wedge cluster randomized&#xD;
        trial we compare clinical outcomes by using a 'urine-first' strategy to 'care-as-usual',&#xD;
        which is a cystoscopy and upper tract imaging in all patients presenting with MH. In&#xD;
        addition, we assess patients' preferences, patients reported outcome measurements, and&#xD;
        healthcare costs to show that a 'urine-first' strategy improves patients' quality of life and&#xD;
        results in a more appropriate use of limited available resources.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 31, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>A multicenter, stepped wedge cluster randomized trial</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>This is a stepped wedge cluster randomized clinical trial</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>The primary aim of the SeARCH-trial is to assess the clinical impact of implementing a molecular urinary assay as a 'urine-first' strategy, in the diagnostic workup of patients presenting with microscopic hematuria.</measure>
      <time_frame>1 year</time_frame>
      <description>The net benefit is defined as the proportion of patients who were diagnose with urinary tract cancer within 1 year after initial diagnostic work-up in the population (true positives) subtracted by the proportion of patients that underwent diagnostic evaluations without an abnormal finding (false positives). The latter is multiplied by the decision threshold, which represents the estimated harms of the diagnostic intervention, such as patients' burden and use of available resources, against the harms of an outcome event, i.e. missing a urinary tract tumor.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The number of cystoscopies and upper tract imaging modalities (CT or ultrasound) when using a 'urine-first' strategy versus 'care-as-usual'</measure>
      <time_frame>1 year</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cost-effectiveness analysis</measure>
      <time_frame>Questionnaires are administered at baseline, 3, 6, and 12 months.</time_frame>
      <description>This will be performed according to the Dutch guideline by administering validated questionnaires.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient reported outcome measurements (PROMs)</measure>
      <time_frame>Questionnaires are administered at baseline, 3, 6, and 12 months.</time_frame>
      <description>Patient-reported outcome measurements (PROMs) are assessed for patients undergoing cystoscopy and urine collection.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1100</enrollment>
    <condition>Hematuria</condition>
    <condition>Urothelial Neoplasm</condition>
    <condition>Urothelial Carcinoma</condition>
    <condition>Bladder Cancer</condition>
    <arm_group>
      <arm_group_label>Care-as-usual</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>In the ''care-as-usual'' arm, all patients undergo 'care-as-usual', i.e. a cystoscopy and upper tract imaging (ultrasound or CT-scan)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>'Urine-first' strategy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In the intervention arm, the urine test is used to triage patients for a diagnostic workup ('urine-first' strategy). Only patients with an abnormal test result undergo cystoscopy and upper tract imaging.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>urine-first strategy</intervention_name>
      <description>Only patients with an abnormal urine test result undergo a diagnostic workup, i.e. cystoscopy and upper-tract imaging.</description>
      <arm_group_label>'Urine-first' strategy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Microscopically confirmed microscopic hematuria of voided urine defined as ≥3&#xD;
               erythrocytes per high power field&#xD;
  &#xD;
            -  Male patients ≥40 years&#xD;
  &#xD;
            -  Female patients ≥50 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of urothelial bladder- or urinary tract cancer&#xD;
  &#xD;
            -  Presence of macroscopic (visible) hematuria&#xD;
  &#xD;
            -  Woman who is or may be pregnant&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>SeARCH-trial Pijpers</name>
        <address>
          <city>Rotterdam</city>
          <zip>3015GD</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>J.L. Boormans, Prof. MD</last_name>
        <phone>0031 107040251</phone>
        <email>search.studie@erasmusmc.nl</email>
      </contact>
      <contact_backup>
        <last_name>O.M. Pijpers, MD</last_name>
      </contact_backup>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
      <investigator_full_name>J.L. Boormans, MD PhD</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Urinary biomarker</keyword>
    <keyword>Hematuria</keyword>
    <keyword>Urothelial Carcinoma</keyword>
    <keyword>Bladder Cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urinary Bladder Neoplasms</mesh_term>
      <mesh_term>Carcinoma, Transitional Cell</mesh_term>
      <mesh_term>Hematuria</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/NCT06026189
  org study id: Erasmus MC
  nct id: NCT06026189
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The SeARCH-trial assess the clinical impact of a molecular urine test as a 'urine-first'
        strategy in the diagnostic workup of patients presenting with microscopic hematuria.
  Microscopic hematuria (MH) can be a sign of an underlying disease, including malignancy of
        the urinary tract, and is reason for referral to a urology clinic. The current standard
        diagnostic workup for MH patients includes visual inspection of the bladder by cystoscopy and
        upper tract imaging to rule out the presence of a tumor in the urinary tract. However, the a
        priori risk of cancer in patients with MH is only 2-5%. Consequently, 95% of MH patients
        unnecessarily undergo invasive procedures, which are: I) uncomfortable and stressful for
        patients, II) has a significant impact on limited available (financial) resources and III) a
        CT scan is accompanied by exposure to ionizing radiation.
  
        Previously we developed a molecular urine assay to detect urinary tract cancer in hematuria
        patients that had robust diagnostic performance; a negative predictive value >99%,
        sensitivity, and specificity >90%. The SeARCH-trial evaluates the clinical impact of a urine
        assay as a 'urine-first' strategy, meaning that only patients with an abnormal urine test
        results undergo invasive diagnostics. In this multicenter stepped-wedge cluster randomized
        trial we compare clinical outcomes by using a 'urine-first' strategy to 'care-as-usual',
        which is a cystoscopy and upper tract imaging in all patients presenting with MH. In
        addition, we assess patients' preferences, patients reported outcome measurements, and
        healthcare costs to show that a 'urine-first' strategy improves patients' quality of life and
        results in a more appropriate use of limited available resources.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A multicenter, stepped wedge cluster randomized trial
  primary purpose: Diagnostic
  masking: None (Open Label)
  masking description: This is a stepped wedge cluster randomized clinical trial
  measure: The primary aim of the SeARCH-trial is to assess the clinical impact of implementing a molecular urinary assay as a 'urine-first' strategy, in the diagnostic workup of patients presenting with microscopic hematuria.
  time frame: 1 year
  description: The net benefit is defined as the proportion of patients who were diagnose with urinary tract cancer within 1 year after initial diagnostic work-up in the population (true positives) subtracted by the proportion of patients that underwent diagnostic evaluations without an abnormal finding (false positives). The latter is multiplied by the decision threshold, which represents the estimated harms of the diagnostic intervention, such as patients' burden and use of available resources, against the harms of an outcome event, i.e. missing a urinary tract tumor.
  measure: The number of cystoscopies and upper tract imaging modalities (CT or ultrasound) when using a 'urine-first' strategy versus 'care-as-usual'
  time frame: 1 year
  measure: Cost-effectiveness analysis
  time frame: Questionnaires are administered at baseline, 3, 6, and 12 months.
  description: This will be performed according to the Dutch guideline by administering validated questionnaires.
  measure: Patient reported outcome measurements (PROMs)
  time frame: Questionnaires are administered at baseline, 3, 6, and 12 months.
  description: Patient-reported outcome measurements (PROMs) are assessed for patients undergoing cystoscopy and urine collection.
  arm group label: Care-as-usual
  arm group type: No Intervention
  description: In the ''care-as-usual'' arm, all patients undergo 'care-as-usual', i.e. a cystoscopy and upper tract imaging (ultrasound or CT-scan)
  arm group label: 'Urine-first' strategy
  arm group type: Experimental
  description: In the intervention arm, the urine test is used to triage patients for a diagnostic workup ('urine-first' strategy). Only patients with an abnormal test result undergo cystoscopy and upper tract imaging.
  intervention type: Diagnostic Test
  intervention name: urine-first strategy
  description: Only patients with an abnormal urine test result undergo a diagnostic workup, i.e. cystoscopy and upper-tract imaging.
  arm group label: 'Urine-first' strategy
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: Erasmus Medical Center
  investigator full name: J.L. Boormans, MD PhD
  investigator title: Professor
  mesh term: Urinary Bladder Neoplasms
  mesh term: Carcinoma, Transitional Cell
  mesh term: Hematuria