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| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
| Center for Advancing Point of Care Technologies | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PointCheck | Device | 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Predictive capacity of PointCheck | 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. |
Inclusion Criteria
Exclusion Criteria
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The study will be conducted in children, and adults diagnosed with cancer that require cytotoxic chemotherapies that could lead to febrile neutropenia. Patients with Diffuse Large B-Cell Non-Hodgkin Lymphoma (DLBCL) and breast cancer who are scheduled to receive cytotoxic chemotherapy agents with high (>20%) or intermediate (10-20%) risk of neutropenia will be the main target. However, all adult patients with Hodgkin/Non-Hodgkin Lymphoma and breast cancer and all children with solid or liquid tumors (see inclusion and exclusion criteria) whose therapy has an intermediate or high-risk of febrile neutropenia, are eligible. The main factor to select the populations will therefore be the estimated risk of severe neutropenia from the chemotherapy used. Patients under any other regimen that have an associated FN risk greater than 10% will be considered eligible.
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| Name | Affiliation | Role |
|---|---|---|
| Branko Cuglievan, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| Sponsor website | View source |
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IPD will not be shared with other researchers
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| 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 |
| Up to three-weeks |
| Diagnostic performance for a second cutoff | 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. | Up to three-weeks |
| Clinical Utility Assessment | Survey completed by the clinical team at the baseline visit assessing the clinical utility of PointCheckTM | Up to three-weeks |