PC004: Usability, Adherence and Diagnostic Performance of PointCheck in Pediatric Population
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| PC004 Cohort 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
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
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Outcome Measures
Primary Outcome Measures
- Usability of PointCheck [Up to two-weeks]
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.
Secondary Outcome Measures
- Accuracy of PointCheck [Up to two-weeks]
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.
- Repeatability of PointCheck [Up to two-weeks]
The % agreement of the device to classify neutropenia compared to the laboratory reference will be established
- Number of participants with device-related adverse events as assessed by CTCAE v5.0 [Up to two-weeks]
The number (and %) of AEs, SAEs and their relationship with the device use will be the safety endpoint
- Adherence to PointCheck [Up to two-weeks]
The number of days that the participant used the device will be used to evaluate adherence.
Other Outcome Measures
- Predictive capacity of PointCheck [Up to two-weeks]
An exploratory analysis about the number of days before the second lab determination that PointCheckTM detected severe neutropenia will be investigated in those participants with severe neutropenia at the nadir visit. Also, exploratory analysis will be conducted in patients developing febrile neutropenia (axillary temperature ≥100.4°F and grade III/IV neutropenia documented in the lab report) during the study to evaluate how many days before the appearance of fever the device detected severe neutropenia during the at home phase of the study.
- Diagnostic performance for a second cutoff [Up to two-weeks]
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 at the nadir (follow up) visit.
- Clinical Utility Assessment [Up to two-weeks]
Survey completed by the clinical team at the baseline visit assessing the clinical utility of PointCheckTM
Eligibility Criteria
Criteria
Inclusion Criteria:
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Study subjects, or their parent/legal guardian for subjects <18 years, must be able to understand the purpose and risks of the study and to 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.
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Male or Female aged 7 years to 39 years.
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Diagnosed with Hodgkin or Non-Hodgkin Lymphoma.
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Scheduled treatment with cytotoxic chemotherapy with an associated high/intermediate risk of neutropenia.
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Able (in the Investigators's opinion) and willing to comply with all study requirements.
Exclusion Criteria:
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Participants with amputations, congenital malformations, or any severe abnormalities of the hands as determined by the investigator.
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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.
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Participants with circulating tumor cells in previous or current lab determinations.
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Participants with leukemia.
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Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor).
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Unstable participants or participants with hypotension (systolic blood pressure <90 and diastolic blood pressure < 60mmHg).
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Leuko Labs, Inc.
- M.D. Anderson Cancer Center
- Center for Advancing Point of Care Technologies in Heart, Lung, Blood and Sleep Disorders
Investigators
- Principal Investigator: Branko Cuglievan, MD, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- MDACC Protocol ID: 2021-0061