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Study to Evaluate the Usability of PointCheck

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04448314
Recruitment Status : Active, not recruiting
First Posted : June 25, 2020
Last Update Posted : October 21, 2021
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Neoplasms Chemotherapy-induced Neutropenia Diagnostic Test: PointCheck

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Study to Evaluate the Usability of PointCheck, a Novel Optical Technology for Screening Non-Invasively Severe Neutropenia
Actual Study Start Date : February 11, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: PointCheck
    This is a usability study on PointCheck, a new technology to detect chemotherapy-induced neutropenia


Primary Outcome Measures :
  1. PointCheck's Usability [ Time Frame: Up to two-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 two-weeks ]
    To confirm the usability of the system using the System Usability Scale


Secondary Outcome Measures :
  1. PointCheck's Precision [ Time Frame: Up to two-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 two-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 two-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 two-weeks ]
    The number (and %) of AEs, SAEs and their relationship with the device use will be the safety endpoint


Other Outcome Measures:
  1. Exploratory diagnostic performance for a second cutoff [ Time Frame: Up to two-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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04448314


Locations
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Spain
Hospital Universitari Dexeus. Grupo Quirónsalud
Barcelona, Spain, 08028
Hospital Universitario 12 de Octubre
Madrid, Spain, 28049
Sponsors and Collaborators
Leuko Labs, Inc.
Investigators
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Principal Investigator: Joaquin Martinez López, MD Fundación de Investigación del Hospital 12 de Octubre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Leuko Labs, Inc.
ClinicalTrials.gov Identifier: NCT04448314    
Other Study ID Numbers: PC001-EU
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: October 21, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Leuko Labs, Inc.:
Medical Device
Technology
Additional relevant MeSH terms:
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Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases