<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/NCT04448314</url>
  </required_header>
  <id_info>
    <org_study_id>PC001-EU</org_study_id>
    <nct_id>NCT04448314</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Usability of PointCheck</brief_title>
  <official_title>Study to Evaluate the Usability of PointCheck, a Novel Optical Technology for Screening Non-Invasively Severe Neutropenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Leuko Labs, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Leuko Labs, Inc.</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This a study about the usability of PointCheck a novel non-invasive technology for monitoring&#xD;
      chemotherapy-induced neutropenia. The study will include patients with cancer visiting the&#xD;
      outpatient hematology clinic for their standard of care chemotherapy administration. A final&#xD;
      sample size of 60 oncologic outpatients will be enrolled and studied with the technology.&#xD;
&#xD;
      The main objective is to evaluate the usability of PointCheck. Secondary outcomes include a&#xD;
      preliminary assessment of PointCheck diagnostic accuracy and precision.&#xD;
&#xD;
      For this, study subjects will be tested twice with PointCheck during the same session and the&#xD;
      usability in an at-home simulated environment by naïve users will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 11, 2020</start_date>
  <completion_date type="Actual">June 30, 2023</completion_date>
  <primary_completion_date type="Actual">June 30, 2023</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>PointCheck's Usability</measure>
    <time_frame>Up to three-weeks</time_frame>
    <description>To gather data with the ultimate goal of determining the usability of the proposed non-invasive method measured by the the number and % of user errors (globally and per error type) observed in the clinic visits. In addition, the number and % of users successfully completing the test without errors will be measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>System Usability Scale (0-100 higher scores indicate better usability)</measure>
    <time_frame>Up to three-weeks</time_frame>
    <description>To confirm the usability of the system using the System Usability Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PointCheck's Precision</measure>
    <time_frame>Up to three-weeks</time_frame>
    <description>To perform an exploratory analysis of the percentage agreement of PointCheck's estimation of WBC from two independent one-minute videos.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PointCheck's Accuracy</measure>
    <time_frame>Up to three-weeks</time_frame>
    <description>To perform a exploratory analysis of PointCheck's accuracy (e.g., sensitivity, specificity, AUROC) to detect severe neutropenia compared with the gold standard blood analysis method employed by the 12 de Octubre Hospital core laboratory in the range between ≤500 and &gt;500 ANC/µL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PointCheck's Utility</measure>
    <time_frame>Up to three-weeks</time_frame>
    <description>To evaluate the % of patients that had to be rescheduled because the sole presence of neutropenia and how many of them were correctly detected with PointCheck.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PointCheck's Safety: total number (%) of AEs and SAEs</measure>
    <time_frame>Up to three-weeks</time_frame>
    <description>The number (and %) of AEs, SAEs and their relationship with the device use will be the safety endpoint</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Exploratory diagnostic performance for a second cutoff</measure>
    <time_frame>Up to three-weeks</time_frame>
    <description>The preliminary diagnostic accuracy to detect grade III neutropenia according to CTCAE V5 (&lt;1000 ANC/mm3) 13 measured by the sensitivity and the specificity will be the evaluated with reference to the corresponding laboratory measures acquired.</description>
  </other_outcome>
  <enrollment type="Actual">94</enrollment>
  <condition>Neoplasms</condition>
  <condition>Chemotherapy-induced Neutropenia</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>PointCheck</intervention_name>
    <description>This is a usability study on PointCheck, a new technology to detect chemotherapy-induced neutropenia</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be conducted in participants with malignancies who are scheduled to receive&#xD;
        cytotoxic chemotherapy agents with any risk of neutropenia (e.g. antimetabolites, platins,&#xD;
        taxanes, topoisomerase inhibitors, Vinca alkaloids, anthracyclines, among others).&#xD;
        Participants will be in an ambulatory stable condition as described in the criteria below&#xD;
        and according to the investigator's assessment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Study subjects must be able to understand the purpose and risks of the study and to&#xD;
             provide signed and dated informed consent and authorization to use confidential health&#xD;
             information in accordance with national and local subject privacy regulations.&#xD;
&#xD;
          2. Male or Female aged 18 years or above&#xD;
&#xD;
          3. Diagnosed with hematological malignancy (e.g., lymphoma, myeloma) or breast cancer.&#xD;
&#xD;
          4. Scheduled active treatment with cytotoxic chemotherapy with an associated&#xD;
             high/intermediate risk of neutropenia.&#xD;
&#xD;
          5. Able (in the Investigators opinion) and willing to comply with all study requirements.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Participants with amputations, congenital malformations or any severe abnormalities of&#xD;
             the hands as determined by the investigator.&#xD;
&#xD;
          2. Participants with a history of vasculitis, Raynaud syndrome, scleroderma, mixed&#xD;
             connective tissue disease or any other rheumatologic systemic condition that could&#xD;
             produce microcirculatory changes in the nailfold.&#xD;
&#xD;
          3. Participants with circulating tumor cells in previous or current lab determinations.&#xD;
&#xD;
          4. Unstable participants or participants with hypotension (systolic blood pressure &lt;90&#xD;
             and diastolic blood pressure &lt; 60mmHg).&#xD;
&#xD;
          5. Any other significant disease or disorder which, in the opinion of the Investigator,&#xD;
             may either put the participants at risk because of participation in the study, or may&#xD;
             influence the result of the study, or the participant's ability to participate in the&#xD;
             study.&#xD;
&#xD;
          6. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make&#xD;
             the subject unsuitable for enrolment.&#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>Joaquin Martinez López, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundación de Investigación del Hospital 12 de Octubre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitari Dexeus. Grupo Quirónsalud</name>
      <address>
        <city>Barcelona</city>
        <zip>08028</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Breast Unit. Oncology Department. 12 Octubre Hospital</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28049</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>August 21, 2023</last_update_submitted>
  <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Medical Device</keyword>
  <keyword>Technology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neutropenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04448314
org study id: PC001-EU
nct id: NCT04448314
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This a study about the usability of PointCheck a novel non-invasive technology for monitoring
      chemotherapy-induced neutropenia. The study will include patients with cancer visiting the
      outpatient hematology clinic for their standard of care chemotherapy administration. A final
      sample size of 60 oncologic outpatients will be enrolled and studied with the technology.

      The main objective is to evaluate the usability of PointCheck. Secondary outcomes include a
      preliminary assessment of PointCheck diagnostic accuracy and precision.

      For this, study subjects will be tested twice with PointCheck during the same session and the
      usability in an at-home simulated environment by naïve users will be evaluated.
observational model: Cohort
time perspective: Other
measure: PointCheck's Usability
time frame: Up to three-weeks
description: To gather data with the ultimate goal of determining the usability of the proposed non-invasive method measured by the the number and % of user errors (globally and per error type) observed in the clinic visits. In addition, the number and % of users successfully completing the test without errors will be measured.
measure: System Usability Scale (0-100 higher scores indicate better usability)
time frame: Up to three-weeks
description: To confirm the usability of the system using the System Usability Scale
measure: PointCheck's Precision
time frame: Up to three-weeks
description: To perform an exploratory analysis of the percentage agreement of PointCheck's estimation of WBC from two independent one-minute videos.
measure: PointCheck's Accuracy
time frame: Up to three-weeks
description: To perform a exploratory analysis of PointCheck's accuracy (e.g., sensitivity, specificity, AUROC) to detect severe neutropenia compared with the gold standard blood analysis method employed by the 12 de Octubre Hospital core laboratory in the range between ≤500 and >500 ANC/µL.
measure: PointCheck's Utility
time frame: Up to three-weeks
description: To evaluate the % of patients that had to be rescheduled because the sole presence of neutropenia and how many of them were correctly detected with PointCheck.
measure: PointCheck's Safety: total number (%) of AEs and SAEs
time frame: Up to three-weeks
description: The number (and %) of AEs, SAEs and their relationship with the device use will be the safety endpoint
measure: Exploratory diagnostic performance for a second cutoff
time frame: Up to three-weeks
description: The preliminary diagnostic accuracy to detect grade III neutropenia according to CTCAE V5 (<1000 ANC/mm3) 13 measured by the sensitivity and the specificity will be the evaluated with reference to the corresponding laboratory measures acquired.
intervention type: Diagnostic Test
intervention name: PointCheck
description: This is a usability study on PointCheck, a new technology to detect chemotherapy-induced neutropenia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joaquin Martinez López, MD
role: Principal Investigator
affiliation: Fundación de Investigación del Hospital 12 de Octubre
facility: 
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Neutropenia
sharing ipd: Undecided