Clinical trial NCT04448314: Study to Evaluate the Usability of PointCheck
Official title: Study to Evaluate the Usability of PointCheck, a Novel Optical Technology for Screening Non-Invasively Severe Neutropenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Chemotherapy-induced Neutropenia
Keywords: Medical Device
Technology
Lead sponsor: Leuko Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-25
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted in participants with malignancies who are scheduled to receive cytotoxic chemotherapy agents with any risk of neutropenia (e.g. antimetabolites, platins, taxanes, topoisomerase inhibitors, Vinca alkaloids, anthracyclines, among others). Participants will be in an ambulatory stable condition as described in the criteria below and according to the investigator's assessment.

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 60 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. Study subjects must be 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 hematological malignancy (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 tumor cells in previous or current lab determinations.
4. Unstable participants or participants with hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmHg).
5. 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.
6. 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 three-weeks
measure: System Usability Scale (0-100 higher scores indicate better usability)
timeFrame: Up to three-weeks
Secondary outcomes:
measure: PointCheck's Precision
timeFrame: Up to three-weeks
measure: PointCheck's Accuracy
timeFrame: Up to three-weeks
measure: PointCheck's Utility
timeFrame: Up to three-weeks
measure: PointCheck's Safety: total number (%) of AEs and SAEs
timeFrame: Up to three-weeks
Other outcomes:
measure: Exploratory diagnostic performance for a second cutoff
timeFrame: Up to three-weeks
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeus. Grupo Quirónsalud
city: Madrid
country: Spain
facility: Breast Unit. Oncology Department. 12 Octubre Hospital
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Fundación de Investigación del Hospital 12 de Octubre
name: Joaquin Martinez López, 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.