<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/NCT04448301</url>
  </required_header>
  <id_info>
    <org_study_id>H-39964</org_study_id>
    <nct_id>NCT04448301</nct_id>
  </id_info>
  <brief_title>PC001- A Study to Evaluate the Usability of PointCheck</brief_title>
  <official_title>PC001 - 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>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </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>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_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.&#xD;
&#xD;
      The study will include patients with cancer visiting the outpatient hematology clinic for&#xD;
      their standard of care chemotherapy administration. A final sample size of 90 oncologic&#xD;
      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 9, 2021</start_date>
  <completion_date type="Actual">June 30, 2023</completion_date>
  <primary_completion_date type="Actual">June 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PointCheck's Usability</measure>
    <time_frame>Up to two-weeks</time_frame>
    <description>To gather data with the ultimate goal of determining the usability of the proposed non-invasive method measured by the number of errors of correct videos acquired for analyses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>System Usability Scale (0-100 higher scores indicates 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 two-weeks</time_frame>
    <description>To perform an exploratory analysis of the precision of PointCheck's estimation of neutropenia status 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, predictive values) to detect severe neutropenia compared with the gold standard blood analysis method employed by Boston Medical Center core laboratory in the range between ≤500 and &gt;500 absolute neutrophil count/µL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PointCheck's Utility</measure>
    <time_frame>Up to three-weeks</time_frame>
    <description>To evaluate the number 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>Number of participants with device-related adverse events as assessed by CTCAE v5.0</measure>
    <time_frame>Up to three-weeks</time_frame>
    <description>To confirm PointCheck's safety determining the % of AEs and SAEs related to the device use.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>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) measured by the sensitivity and the specificity will be the evaluated with reference to the corresponding laboratory measures acquired.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Neoplasms</condition>
  <condition>Neutropenia</condition>
  <arm_group>
    <arm_group_label>PointCheck Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <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>
    <arm_group_label>PointCheck Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Able to understand the purpose and risks of the study and to provide signed and dated&#xD;
             informed consent and authorization to use confidential health information in&#xD;
             accordance with national and local subject privacy regulations.&#xD;
&#xD;
          2. Male or Female aged 18 years or above.&#xD;
&#xD;
          3. Diagnosed with a hematological (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&#xD;
             of 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 tumour cells in previous or current lab determinations.&#xD;
&#xD;
          4. Participants with leukemia.&#xD;
&#xD;
          5. Participants with any condition producing significant tremor (e.g., essential tremor,&#xD;
             Parkinson´s disease, dystonic tremor).&#xD;
&#xD;
          6. Inadequately medically controlled hypotension (systolic blood pressure &lt;90 and&#xD;
             diastolic blood pressure &lt; 60mmHg).&#xD;
&#xD;
          7. Participants whose gold standard blood differential was obtained more than 120 minutes&#xD;
             after the last evaluation with the medical device.&#xD;
&#xD;
          8. 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;
          9. 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>Mark Sloan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 11, 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>
  <keyword>Non-invasive</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>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/NCT04448301
org study id: H-39964
nct id: NCT04448301
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
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 90 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
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: PointCheck's Usability
time frame: Up to two-weeks
description: To gather data with the ultimate goal of determining the usability of the proposed non-invasive method measured by the number of errors of correct videos acquired for analyses.
measure: System Usability Scale (0-100 higher scores indicates 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 two-weeks
description: To perform an exploratory analysis of the precision of PointCheck's estimation of neutropenia status 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, predictive values) to detect severe neutropenia compared with the gold standard blood analysis method employed by Boston Medical Center core laboratory in the range between ≤500 and >500 absolute neutrophil count/µL.
measure: PointCheck's Utility
time frame: Up to three-weeks
description: To evaluate the number of patients that had to be rescheduled because the sole presence of neutropenia and how many of them were correctly detected with PointCheck.
measure: Number of participants with device-related adverse events as assessed by CTCAE v5.0
time frame: Up to three-weeks
description: To confirm PointCheck's safety determining the % of AEs and SAEs related to the device use.
measure: 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) measured by the sensitivity and the specificity will be the evaluated with reference to the corresponding laboratory measures acquired.
arm group label: PointCheck Cohort
arm group type: Experimental
intervention type: Diagnostic Test
intervention name: PointCheck
description: This is a usability study on PointCheck, a new technology to detect chemotherapy-induced neutropenia
arm group label: PointCheck Cohort
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark Sloan, MD
role: Principal Investigator
affiliation: Boston Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neutropenia
sharing ipd: No