Back to resultsPC001- A Study to Evaluate the Usability of PointCheck
Primary Purpose
Neoplasms, Neutropenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PointCheck
Sponsored by
About this trial
This is an interventional diagnostic trial for Neoplasms focused on measuring Medical Device, Technology, Non-invasive
Eligibility Criteria
Inclusion Criteria:
- 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 a hematological (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 tumour cells in previous or current lab determinations.
- Participants with leukemia.
- Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor).
- Inadequately medically controlled hypotension (systolic blood pressure <90 and diastolic blood pressure < 60mmHg).
- Participants whose gold standard blood differential was obtained more than 120 minutes after the last evaluation with the medical device.
- 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.
Sites / Locations
- Boston Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PointCheck Cohort
Arm Description
Outcomes
Primary Outcome Measures
PointCheck's Usability
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.
System Usability Scale (0-100 higher scores indicates better usability)
To confirm the usability of the system using the System Usability Scale
Secondary Outcome Measures
PointCheck's Precision
To perform an exploratory analysis of the precision of PointCheck's estimation of neutropenia status from two independent one-minute videos.
PointCheck's Accuracy
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.
PointCheck's Utility
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.
Number of participants with device-related adverse events as assessed by CTCAE v5.0
To confirm PointCheck's safety determining the % of AEs and SAEs related to the device use.
Full Information
NCT ID
NCT04448301
First Posted
June 11, 2020
Last Updated
August 21, 2023
Sponsor
Leuko Labs, Inc.
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04448301
Brief Title
PC001- A Study to Evaluate the Usability of PointCheck
Official Title
PC001 - Study to Evaluate the Usability of PointCheck, a Novel Optical Technology for Screening Non-Invasively Severe Neutropenia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 9, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Leuko Labs, Inc.
Collaborators
National Cancer Institute (NCI)
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Neutropenia
Keywords
Medical Device, Technology, Non-invasive
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PointCheck Cohort
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
PointCheck
Intervention Description
This is a usability study on PointCheck, a new technology to detect chemotherapy-induced neutropenia
Primary Outcome Measure Information:
Title
PointCheck's Usability
Description
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.
Time Frame
Up to two-weeks
Title
System Usability Scale (0-100 higher scores indicates better usability)
Description
To confirm the usability of the system using the System Usability Scale
Time Frame
Up to three-weeks
Secondary Outcome Measure Information:
Title
PointCheck's Precision
Description
To perform an exploratory analysis of the precision of PointCheck's estimation of neutropenia status from two independent one-minute videos.
Time Frame
Up to two-weeks
Title
PointCheck's Accuracy
Description
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.
Time Frame
Up to three-weeks
Title
PointCheck's Utility
Description
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.
Time Frame
Up to three-weeks
Title
Number of participants with device-related adverse events as assessed by CTCAE v5.0
Description
To confirm PointCheck's safety determining the % of AEs and SAEs related to the device use.
Time Frame
Up to three-weeks
Other Pre-specified Outcome Measures:
Title
Diagnostic performance for a second cutoff
Description
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.
Time Frame
Up to three-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 a hematological (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 tumour cells in previous or current lab determinations.
Participants with leukemia.
Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor).
Inadequately medically controlled hypotension (systolic blood pressure <90 and diastolic blood pressure < 60mmHg).
Participants whose gold standard blood differential was obtained more than 120 minutes after the last evaluation with the medical device.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Sloan, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35943786
Citation
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.
Results Reference
derived
Learn more about this trial
PC001- A Study to Evaluate the Usability of PointCheck
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