Neoplasms, Neutropenia
Conditions
Keywords
Medical Device, Technology, Non-invasive
Brief summary
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
Interventions
DIAGNOSTIC_TESTPointCheck
This is a usability study on PointCheck, a new technology to detect chemotherapy-induced neutropenia
Sponsors
National Cancer Institute (NCI)
Leuko Labs, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Male or Female aged 18 years or above. 3. Diagnosed with a hematological (e.g., lymphoma, myeloma) or breast cancer. 4. Scheduled active treatment with cytotoxic chemotherapy with an associated high/intermediate risk of neutropenia. 5. Able (in the Investigators opinion) and willing to comply with all study requirements
Exclusion criteria
1. Participants with amputations, congenital malformations, or any severe abnormalities of the hands as determined by the investigator. 2. 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. 3. Participants with circulating tumour cells in previous or current lab determinations. 4. Participants with leukemia. 5. Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor). 6. Inadequately medically controlled hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmHg). 7. Participants whose gold standard blood differential was obtained more than 120 minutes after the last evaluation with the medical device. 8. 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. 9. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale (0-100 higher scores indicates better usability) | Up to three-weeks | To confirm the usability of the system using the System Usability Scale |
| PointCheck's Usability | Up to two-weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PointCheck's Accuracy | Up to three-weeks | 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. |
| Number of participants with device-related adverse events as assessed by CTCAE v5.0 | Up to three-weeks | To confirm PointCheck's safety determining the % of AEs and SAEs related to the device use. |
| PointCheck's Utility | Up to three-weeks | 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. |
| PointCheck's Precision | Up to two-weeks | To perform an exploratory analysis of the precision of PointCheck's estimation of neutropenia status from two independent one-minute videos. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance for a second cutoff | Up to three-weeks | 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. |
Countries
United States
Outcome results
None listed