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Trial record 1 of 1 for:    NCT04448301
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PC001- A Study to Evaluate the Usability of PointCheck

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ClinicalTrials.gov Identifier: NCT04448301
Recruitment Status : Recruiting
First Posted : June 25, 2020
Last Update Posted : April 7, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
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 90 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 Phase
Neoplasms Neutropenia Diagnostic Test: PointCheck Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PC001 - Study to Evaluate the Usability of PointCheck, a Novel Optical Technology for Screening Non-Invasively Severe Neutropenia
Actual Study Start Date : February 9, 2021
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : September 5, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PointCheck Cohort 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 number of errors of correct videos acquired for analyses.

  2. System Usability Scale (0-100 higher scores indicates 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 precision of PointCheck's estimation of neutropenia status 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, predictive values) to detect severe neutropenia compared with the gold standard blood analysis method employed by Boston Medical Center core laboratory in the range between ≤500 and >500 absolute neutrophil count/µL.

  3. PointCheck's Utility [ Time Frame: Up to two-weeks ]
    To evaluate the number of patients that had to be rescheduled because the sole presence of neutropenia and how many of them were correctly detected with PointCheck.

  4. Number of participants with device-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Up to two-weeks ]
    To confirm PointCheck's safety determining the % of AEs and SAEs related to the device use.


Other Outcome Measures:
  1. 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) 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
Criteria

Inclusion Criteria:

  1. 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 a hematological (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 tumour cells in previous or current lab determinations.
  4. Participants with leukemia.
  5. Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor).
  6. Inadequately medically controlled hypotension (systolic blood pressure <90 and diastolic blood pressure < 60mmHg).
  7. Participants whose gold standard blood differential was obtained more than 120 minutes after the last evaluation with the medical device.
  8. 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.
  9. 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): NCT04448301


Contacts
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Contact: Álvaro Sánchez-Ferro, MD +34619223086 alvaro@leuko.io

Locations
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United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Mark Sloan, MD         
Sponsors and Collaborators
Leuko Labs, Inc.
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Mark Sloan, MD Boston Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Leuko Labs, Inc.
ClinicalTrials.gov Identifier: NCT04448301    
Other Study ID Numbers: H-39964
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: April 7, 2022
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Leuko Labs, Inc.:
Medical Device
Technology
Non-invasive
Additional relevant MeSH terms:
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Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases