Clinical trial NCT04448301: PC001- A Study to Evaluate the Usability of PointCheck
Official title: PC001 - Study to Evaluate the Usability of PointCheck, a Novel Optical Technology for Screening Non-Invasively Severe Neutropenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms
Neutropenia
Keywords: Medical Device
Technology
Non-invasive
Lead sponsor: Leuko Labs, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-06-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: 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.

Primary outcomes:
measure: PointCheck's Usability
timeFrame: Up to two-weeks
measure: System Usability Scale (0-100 higher scores indicates better usability)
timeFrame: Up to three-weeks
Secondary outcomes:
measure: PointCheck's Precision
timeFrame: Up to two-weeks
measure: PointCheck's Accuracy
timeFrame: Up to three-weeks
measure: PointCheck's Utility
timeFrame: Up to three-weeks
measure: Number of participants with device-related adverse events as assessed by CTCAE v5.0
timeFrame: Up to three-weeks
Other outcomes:
measure: Diagnostic performance for a second cutoff
timeFrame: Up to three-weeks
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Mark Sloan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.