Study to Evaluate the Usability of PointCheck

Completed

• Conditions: Neoplasms; Chemotherapy-induced Neutropenia

• Registration Number: NCT04448314
• Lead Sponsor: Leuko Labs, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-11
• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-24
• Study First Posted: 2020-06-25
• Status Verified: 2023-03
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PointCheck's Usability	Up to three-weeks	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.
System Usability Scale (0-100 higher scores indicate better usability)	Up to three-weeks	To confirm the usability of the system using the System Usability Scale

Secondary Outcome Measures

Name	Time	Method
PointCheck's Precision	Up to three-weeks	To perform an exploratory analysis of the percentage agreement of PointCheck's estimation of WBC from two independent one-minute videos.
PointCheck's Utility	Up to three-weeks	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.
PointCheck's Safety: total number (%) of AEs and SAEs	Up to three-weeks	The number (and %) of AEs, SAEs and their relationship with the device use will be the safety endpoint
PointCheck's Accuracy	Up to three-weeks	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.

Trial Locations

Locations (3)

Hospital Universitari Dexeus. Grupo Quirónsalud; 🇪🇸 Barcelona, Spain

Breast Unit. Oncology Department. 12 Octubre Hospital; 🇪🇸 Madrid, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain