Study to Evaluate the Usability of PointCheck

Study to Evaluate the Usability of PointCheck, a Novel Optical Technology for Screening Non-Invasively Severe Neutropenia

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms; Chemotherapy-induced Neutropenia
• Intervention / Treatment: Diagnostic test: PointCheck

• Study Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08028
    • Hospital Universitari Dexeus. Grupo Quirónsalud
  • Madrid, Spain, 28049
    • Hospital Universitario 12 de octubre
  • Madrid, Spain, 28041
    • Breast Unit. Oncology Department. 12 Octubre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PointCheck's Usability	To gather data with the ultimate goal of determining the usability of the proposed non-invasive method measured by the the number and % of user errors (globally and per error type) observed in the clinic visits. In addition, the number and % of users successfully completing the test without errors will be measured.	Up to three-weeks
System Usability Scale (0-100 higher scores indicate better usability)	To confirm the usability of the system using the System Usability Scale	Up to three-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PointCheck's Precision	To perform an exploratory analysis of the percentage agreement of PointCheck's estimation of WBC from two independent one-minute videos.	Up to three-weeks
PointCheck's Accuracy	To perform a exploratory analysis of PointCheck's accuracy (e.g., sensitivity, specificity, AUROC) to detect severe neutropenia compared with the gold standard blood analysis method employed by the 12 de Octubre Hospital core laboratory in the range between ≤500 and >500 ANC/µL.	Up to three-weeks
PointCheck's Utility	To evaluate the % of patients that had to be rescheduled because the sole presence of neutropenia and how many of them were correctly detected with PointCheck.	Up to three-weeks
PointCheck's Safety: total number (%) of AEs and SAEs	The number (and %) of AEs, SAEs and their relationship with the device use will be the safety endpoint	Up to three-weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory 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.	Up to three-weeks

Collaborators and Investigators

• Sponsor: Leuko Labs, Inc.
• Investigators: Principal Investigator: Joaquin Martinez López, MD, Fundación de Investigación del Hospital 12 de Octubre

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2020
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 24, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Medical Device; Technology
• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neutropenia
• Other Study ID Numbers: PC001-EU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No