Boston Medical Center
Boston, Massachusetts, 02118, United States
NCT Number: NCT04448301
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02118, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This is a usability study on PointCheck, a new technology to detect chemotherapy-induced neutropenia
Time frame: 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.
Time frame: Up to three-weeks
To confirm the usability of the system using the System Usability Scale
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to three-weeks
To confirm PointCheck's safety determining the % of AEs and SAEs related to the device use.
Time frame: 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.
Leuko Labs, Inc.
Industry
PC001 - Study to Evaluate the Usability of PointCheck, a Novel Optical Technology for Screening Non-Invasively Severe Neutropenia
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