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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PointCheck Cohort | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PointCheck | Diagnostic Test | This is a usability study on PointCheck, a new technology to detect chemotherapy-induced neutropenia |
|
| Measure | Description | Time Frame |
|---|---|---|
| PointCheck's Usability | 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. | Up to two-weeks |
| System Usability Scale (0-100 higher scores indicates better usability) | To confirm the usability of the system using the System Usability Scale | Up to three-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PointCheck's Precision | To perform an exploratory analysis of the precision of PointCheck's estimation of neutropenia status from two independent one-minute videos. | Up to two-weeks |
| PointCheck's Accuracy |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance for a second cutoff | 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. | Up to three-weeks |
Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Mark Sloan, MD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35943786 | Derived | Lamaj G, Pablo-Trinidad A, Butterworth I, Bell N, Benasutti R, Bourquard A, Sanchez-Ferro A, Castro-Gonzalez C, Jimenez-Ubieto A, Baumann T, Rodriguez-Izquierdo A, Pottier E, Shelton A, Martinez-Lopez J, Sloan JM. Usability Evaluation of a Noninvasive Neutropenia Screening Device (PointCheck) for Patients Undergoing Cancer Chemotherapy: Mixed Methods Observational Study. J Med Internet Res. 2022 Aug 9;24(8):e37368. doi: 10.2196/37368. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
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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.
| Up to three-weeks |
| PointCheck's Utility | 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. | Up to three-weeks |
| Number of participants with device-related adverse events as assessed by CTCAE v5.0 | To confirm PointCheck's safety determining the % of AEs and SAEs related to the device use. | Up to three-weeks |
| D006425 |
| Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |