Usability, Adherence and Diagnostic Performance of PointCheck in Pediatric Population

Study Overview
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Brief Summary
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Single-site non-significant risk, open-label clinical investigation designed to validate the usability, adherence, and preliminary diagnostic performance of a novel technology to detect neutropenia. Study participants will be managed as per the standard of care practice with a baseline and nadir visit including laboratory determinations. Participants will also be evaluated with the device at both time points and with daily measurements during the two-week period in between.

Official Title
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A Study to Evaluate the Usability, Adherence and Diagnostic Performance of a Novel System to Non-Invasively Detect Severe Neutropenia

Conditions
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Hematologic Malignancy

Intervention / Treatment
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* Device: PointCheck


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Study subjects, or their parent/legal guardian for subjects <18 years, must be able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. Subjects between the ages of 7 and 17.9 years must provide assent. Male or Female aged 7 years to 65 years. Adults (> 18 years) diagnosed Diagnosed with Hodgkin/Non-Hodgkin Lymphoma or breast cancer. Children and adolescents (7 - 18 years) with liquid or solid tumors. Scheduled treatment with cytotoxic chemotherapy with an associated high/intermediate risk of neutropenia (table 1) 30. Able (in the investigator's opinion) and willing to comply with all study requirements. Exclusion Criteria Participants with amputations, congenital malformations, or any severe abnormalities of the hands as determined by the investigator. Participants with a history of vasculitis, Raynaud syndrome, scleroderma, mixed connective tissue disease, or any other rheumatologic systemic condition that could produce microcirculatory changes in the nailfold. Participants with circulating tumor cells in previous or current lab determinations. Adult (>18 years) participants with leukemia of all types and pediatric (7-18 years) participants with leukemia that are either not in remission or in the minimal residual disease category. Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor). Unstable participants (pediatric or adults) or adult participants with hypotension (systolic blood pressure <90 and diastolic blood pressure < 60mmHg). Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PC004 Cohort<br>The study will include a sample of patients with specific cancer types visiting the outpatient hematologic oncology clinic for their standard of care chemotherapy administration. Participants will need to be willing to participate and be able to provide written informed consent | Device: PointCheck<br>* PointCheckTM is intended for use to aid in the assessment of severe neutropenia in the home or clinic setting in subjects receiving myelosuppressive chemotherapy with intermediate to high febrile neutropenia risk. The device non-invasively captures real-time videos of blood flow in the nailfold microcirculation and utilizes visible light, a microscope and a computer vision software to provide a qualitative result. The device is limited to use as a preliminary assessment tool in conjunction with standard of care, including temperature monitoring and clinical assessment. It is not to be used as a stand-alone determinant of severe neutropenia or for any other diagnostic purpose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of PointCheck | The study will confirm if participants can acquire good quality videos in a home like setting. The System Usability Scale (0-100 higher scored indicate a better usability) will be completed by the participants after completing the follow up visit. | Up to three-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of PointCheck | The preliminary diagnostic accuracy to detect grade IV neutropenia according to CTCAE V5 (<500 ANC/mm3) measured by the sensitivity and the specificity will be the evaluated with reference to the corresponding laboratory measures acquired at the nadir (follow up) visit. | Up to three-weeks | 
| Repeatability of PointCheck | The % agreement of the device to classify neutropenia compared to the laboratory reference will be established | Up to three-weeks | 
| Number of participants with device-related adverse events as assessed by CTCAE v5.0 | The number (and %) of AEs, SAEs and their relationship with the device use will be the safety endpoint | Up to three-weeks | 
| Adherence to PointCheck | The number of days that the participant used the device will be used to evaluate adherence. | Up to three-weeks |