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/NCT05962944</url>
    </required_header>
    <id_info>
      <org_study_id>RoyalCornwallHT</org_study_id>
      <nct_id>NCT05962944</nct_id>
    </id_info>
    <brief_title>Remote Rapid Onsite Evaluation (ROSE) for Head and Neck Fine Needle Aspirations (FNA)</brief_title>
    <acronym>Remote ROSE</acronym>
    <official_title>Remote Rapid On-site Evaluation (ROSE) for Head and Neck Fine Needle Aspirations (FNA)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Royal Cornwall Hospitals Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Royal Cornwall Hospitals 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>
        Rapid On-Site Evaluation (ROSE) of cytology FNA samples performed by a Pathologist or&#xD;
        Biomedical Scientist is a real time morphological assessment of the sample in the clinical&#xD;
        setting with the aim of acquiring all the diagnostic material in one appointment resulting in&#xD;
        reduction in costs, improved patient care and reduced referral to treatment time.&#xD;
  &#xD;
        It is not practical or possible for the ROSE team to be present in every location where an&#xD;
        FNA is performed. Telecytology (TC) or remote ROSE is a digital form of ROSE which allows a&#xD;
        biomedical scientist or pathologist working in a remote laboratory to review the cytology&#xD;
        slides in real time, using microscope images fed from the location where the FNA procedure is&#xD;
        being performed.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The new faster diagnostic standards (FDS) alongside NICE guidance and the British association&#xD;
        of Head and Neck Oncologists (BAHNO) guidelines, state that ROSE should be provided for all&#xD;
        FNA's. It is not practical or possible for the ROSE team to be present in every location&#xD;
        where an FNA is performed. Telecytology (TC) or remote ROSE is a digital form of ROSE which&#xD;
        allows a biomedical scientist or pathologist working in a remote laboratory to review the&#xD;
        cytology slides in real time, using microscope images fed from the location where the FNA&#xD;
        procedure is being performed.&#xD;
  &#xD;
        A trained a clinical imaging assistant (CIA) will prepare the slides and drive the microscope&#xD;
        in the ultrasound room. Using the Olympus software Cellsens and the screen share option in&#xD;
        Microsoft teams, the remote biomedical scientist / pathologist will be able to assess the&#xD;
        sample in real time and provide both verbal and written methods of communication (relevant&#xD;
        clinical information and instructions). An additional camera will allow visualisation of the&#xD;
        slide preparation and residual material in real time to the scientist / pathologist&#xD;
        performing the assessment.&#xD;
  &#xD;
        This study will investigate whether ROSE can be performed remotely. This study will be based&#xD;
        in the cytology department at the Royal Cornwall Hospital as part of a service improvement.&#xD;
        Phase 2 will involve the use of the Tower Block ultrasound room located on the Royal Cornwall&#xD;
        Hospitals Truro site and in phase 3 the ultrasound room at The Royal Cornwall Hospital's&#xD;
        Camborne and Redruth site.&#xD;
  &#xD;
        Patients between the ages of 18 and 90 years attending for an ultrasound guided fine needle&#xD;
        aspiration of lesions in the head and neck and supraclavicular fossa nodes will be consented&#xD;
        for remote ROSE to be performed over a 12-month period.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 25, 2022</start_date>
    <completion_date type="Actual">July 24, 2023</completion_date>
    <primary_completion_date type="Actual">June 15, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Rapid on site evaluation can be provided using telecytology</measure>
      <time_frame>12 months</time_frame>
      <description>To robustly test the concept of remote rapid on site evaluation for head and neck.&#xD;
  The Scientist performing the remote ROSE will record the assessment findings:&#xD;
  Inadequate sampling - Advise repeat sampling&#xD;
  Adequate sampling - Stop procedure.&#xD;
  Diagnostic sampling but more material required. - Advise repeat sampling&#xD;
  Diagnostic sampling and sufficient cell yield - Stop procedure These findings will be compared with the final diagnostic outcomes (Final report) issued by the laboratory. The overall effectiveness of remote ROSE will be compared against current practice for head and neck FNA in terms of adequacy and diagnostic yield. If over 80% of samples obtained with remote ROSE are deemed adequate and sufficient then the trial will be regarded as successful. This prevents the majority of patients having to return for additional appointments and procedures.</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">25</enrollment>
    <condition>Head and Neck Neoplasms</condition>
    <arm_group>
      <arm_group_label>Laboratory testing</arm_group_label>
      <description>Slides reviewed in the laboratory to test the platform for suitability prior to involving patients</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Remote ROSE on the same site as the laboratory</arm_group_label>
      <description>The next phase will involve remote ROSE being performed on the same site as the laboratory in an ultrasound room located on the Royal Cornwall Hospitals Truro site.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Remote ROSE at a site external to the laboratory</arm_group_label>
      <description>Phase 3 will involved remote ROSE being performed on a different site to the laboratory. The ultrasound room at The Royal Cornwall Hospital's Camborne and Redruth site.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Olympus Cellsens software</intervention_name>
      <description>Olympus cellsens software will be used to visualise the cells and MS teams screen share will be used to send the live images in real time.</description>
      <arm_group_label>Laboratory testing</arm_group_label>
      <arm_group_label>Remote ROSE at a site external to the laboratory</arm_group_label>
      <arm_group_label>Remote ROSE on the same site as the laboratory</arm_group_label>
      <other_name>Microsoft teams</other_name>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Cytology fine needle aspiration samples&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Participants attending for an ultrasound guided fine needle aspiration of lesions in the&#xD;
          head and neck and supraclavicular fossa nodes.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male and female participants &gt; 18-90 years of age&#xD;
  &#xD;
            -  Participants attending for an ultrasound guided fine needle aspiration of lesions in&#xD;
               the head and neck and supraclavicular fossa nodes.&#xD;
  &#xD;
            -  All ethnicity or socioeconomic grouping that require an US FNA at RCHT over the&#xD;
               12-month study period.&#xD;
  &#xD;
            -  Able and willing to consent to the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Anyone &lt;18 years of age&#xD;
  &#xD;
            -  Patients that do not require an FNA after the initial ultrasound&#xD;
  &#xD;
            -  Any participants considered vulnerable will not be included in the study.&#xD;
  &#xD;
            -  This study involves testing the concept of remote ROSE rather than direct impact on&#xD;
               patient care needs related to ethical of communication issues. For practical&#xD;
               considerations and to prevent unnecessary anxiety for patients who are unable to read&#xD;
               the information sheets and provide consent, these patients will not be included in the&#xD;
               study.&#xD;
  &#xD;
            -  Unable or unwilling to consent to the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>19 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Leonie Wheeldon</last_name>
      <role>Principal Investigator</role>
      <affiliation>Royal Cornwall Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Royal Cornwall Hospital</name>
        <address>
          <city>Truro</city>
          <state>Cornwall</state>
          <zip>TR1 3LJ</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 29, 2022</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 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>Head and Neck Neoplasms</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/NCT05962944
  org study id: RoyalCornwallHT
  nct id: NCT05962944
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Rapid On-Site Evaluation (ROSE) of cytology FNA samples performed by a Pathologist or
        Biomedical Scientist is a real time morphological assessment of the sample in the clinical
        setting with the aim of acquiring all the diagnostic material in one appointment resulting in
        reduction in costs, improved patient care and reduced referral to treatment time.
  
        It is not practical or possible for the ROSE team to be present in every location where an
        FNA is performed. Telecytology (TC) or remote ROSE is a digital form of ROSE which allows a
        biomedical scientist or pathologist working in a remote laboratory to review the cytology
        slides in real time, using microscope images fed from the location where the FNA procedure is
        being performed.
  The new faster diagnostic standards (FDS) alongside NICE guidance and the British association
        of Head and Neck Oncologists (BAHNO) guidelines, state that ROSE should be provided for all
        FNA's. It is not practical or possible for the ROSE team to be present in every location
        where an FNA is performed. Telecytology (TC) or remote ROSE is a digital form of ROSE which
        allows a biomedical scientist or pathologist working in a remote laboratory to review the
        cytology slides in real time, using microscope images fed from the location where the FNA
        procedure is being performed.
  
        A trained a clinical imaging assistant (CIA) will prepare the slides and drive the microscope
        in the ultrasound room. Using the Olympus software Cellsens and the screen share option in
        Microsoft teams, the remote biomedical scientist / pathologist will be able to assess the
        sample in real time and provide both verbal and written methods of communication (relevant
        clinical information and instructions). An additional camera will allow visualisation of the
        slide preparation and residual material in real time to the scientist / pathologist
        performing the assessment.
  
        This study will investigate whether ROSE can be performed remotely. This study will be based
        in the cytology department at the Royal Cornwall Hospital as part of a service improvement.
        Phase 2 will involve the use of the Tower Block ultrasound room located on the Royal Cornwall
        Hospitals Truro site and in phase 3 the ultrasound room at The Royal Cornwall Hospital's
        Camborne and Redruth site.
  
        Patients between the ages of 18 and 90 years attending for an ultrasound guided fine needle
        aspiration of lesions in the head and neck and supraclavicular fossa nodes will be consented
        for remote ROSE to be performed over a 12-month period.
  observational model: Case-Only
  time perspective: Prospective
  measure: Rapid on site evaluation can be provided using telecytology
  time frame: 12 months
  description: To robustly test the concept of remote rapid on site evaluation for head and neck.
  The Scientist performing the remote ROSE will record the assessment findings:
  Inadequate sampling - Advise repeat sampling
  Adequate sampling - Stop procedure.
  Diagnostic sampling but more material required. - Advise repeat sampling
  Diagnostic sampling and sufficient cell yield - Stop procedure These findings will be compared with the final diagnostic outcomes (Final report) issued by the laboratory. The overall effectiveness of remote ROSE will be compared against current practice for head and neck FNA in terms of adequacy and diagnostic yield. If over 80% of samples obtained with remote ROSE are deemed adequate and sufficient then the trial will be regarded as successful. This prevents the majority of patients having to return for additional appointments and procedures.
  arm group label: Laboratory testing
  description: Slides reviewed in the laboratory to test the platform for suitability prior to involving patients
  arm group label: Remote ROSE on the same site as the laboratory
  description: The next phase will involve remote ROSE being performed on the same site as the laboratory in an ultrasound room located on the Royal Cornwall Hospitals Truro site.
  arm group label: Remote ROSE at a site external to the laboratory
  description: Phase 3 will involved remote ROSE being performed on a different site to the laboratory. The ultrasound room at The Royal Cornwall Hospital's Camborne and Redruth site.
  intervention type: Device
  intervention name: Olympus Cellsens software
  description: Olympus cellsens software will be used to visualise the cells and MS teams screen share will be used to send the live images in real time.
  arm group label: Laboratory testing
  arm group label: Remote ROSE at a site external to the laboratory
  arm group label: Remote ROSE on the same site as the laboratory
  other name: Microsoft teams
  Cytology fine needle aspiration samples
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 19 Years
  healthy volunteers: No
  last name: Leonie Wheeldon
  role: Principal Investigator
  affiliation: Royal Cornwall Hospital
  facility: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Head and Neck Neoplasms