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Completed

NCT Number: NCT04448314

Study to Evaluate the Usability of PointCheck

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.

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Key information

Conditions

Neoplasms Chemotherapy-induced Neutropenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitari Dexeus. Grupo Quirónsalud, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Male or Female aged 18 years or above
  • Diagnosed with hematological malignancy (e.g., lymphoma, myeloma) or breast cancer.
  • Scheduled active treatment with cytotoxic chemotherapy with an associated high/intermediate risk of neutropenia.
  • Able (in the Investigators opinion) and willing to comply with all study requirements.

Exclusion criteria

  • Participants with amputations, congenital malformations or any severe abnormalities of the hands as determined by the investigator.
  • 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.
  • Participants with circulating tumor cells in previous or current lab determinations.
  • Unstable participants or participants with hypotension (systolic blood pressure <90 and diastolic blood pressure < 60mmHg).
  • 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.
  • Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.

Treatment and study plan

PointCheck

Diagnostic Test

This is a usability study on PointCheck, a new technology to detect chemotherapy-induced neutropenia

Primary outcomes

  1. PointCheck's Usability

    Time frame: 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.

  2. System Usability Scale (0-100 higher scores indicate better usability)

    Time frame: Up to three-weeks

    To confirm the usability of the system using the System Usability Scale

Secondary outcomes

  1. PointCheck's Precision

    Time frame: 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.

  2. PointCheck's Accuracy

    Time frame: 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.

  3. PointCheck's Utility

    Time frame: 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.

  4. PointCheck's Safety: total number (%) of AEs and SAEs

    Time frame: Up to three-weeks

    The number (and %) of AEs, SAEs and their relationship with the device use will be the safety endpoint

Other outcomes

  1. Exploratory diagnostic performance for a second cutoff

    Time frame: Up to three-weeks

    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.

Sponsors and collaborators

Lead sponsor

Leuko Labs, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 25, 2020
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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