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Pivotal study to validate the diagnostic performance of PointCheck, the first non invasive device to preliminary detect neutropenia in cancer patients receiving intermediate/high risk antineoplastic therapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PointCheck | Diagnostic Test | Binary classification of severe neutropenia |
| Measure | Description | Time Frame |
|---|---|---|
| PointCheck Accuracy | The main primary endpoints for this study will be the sensitivity and specificity of PointCheckTM to detect grade IV neutropenia ac cording to the CTCAE V5 definition of severe neutropenia in a standard blood analysis. | Two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PointCheck Precision | Repeatability and reproducibility will be assessed using the % positive/negative results of the test's classification compared to the gold standard after multiple measurements in different contexts. | Two-weeks |
| PointCheck Usability |
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Inclusion Criteria:
Exclusion Criteria:
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This is a multi-site (4 US sites) observational open-label diagnostic study of a non-significant risk medical device, PointCheckTM. Participants (N=210) with specific malignancies who are scheduled to receive antineoplastic therapy will be evaluated during their routine management before the planned cytotoxic drug administration at two-time points (baseline and nadir evaluation). This will be an event-driven study with a total number of 70 positive cases (ANC < 500 cells/mm3) and 140 negative cases (ANC >= 500 cells/mm3) has been considered sufficient to provide accurate estimates of Sensitivity and Specificity. They will have concurrent evaluations with PointCheckTM and a blood differential cell count in addition to the standard clinical visits. A subset (N=45) of patients will be evaluated for between-instrument reproducibility. Finally, a sub-study (N=30) will confirm the usability of PointCheckTM in the home setting.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alvaro Sanchez-Ferro, MD, PhD | Contact | +1 617 419 0974 | alvaro@leuko.io |
| Name | Affiliation | Role |
|---|---|---|
| Carlos Castro Gonzalez, PhD | Leuko Labs | Principal Investigator |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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Mean System Usability Score |
| Two-weeks |
| PointCheck Errors | Device related errors (number/type) | Two-weeks |
| PointCheck Safety | total number (and %) of AEs and SAEs related to the device use. | Two-weeks |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |