NeoplasmsNCT04448314
Study to Evaluate the Usability of PointCheck
An observational study of Neoplasms and Chemotherapy-induced Neutropenia, run by Leuko Labs, Inc. at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Chemotherapy-induced Neutropenia
- What is being tested?
- PointCheck
- How many people
- 94 participants
- Where
- 3 sitesSpain
- Study dates
- 11 Feb 2020to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Universitari Dexeus. Grupo Quirónsalud
Barcelona, 08028
Breast Unit. Oncology Department. 12 Octubre Hospital
Madrid, 28041
Hospital Universitario 12 de Octubre
Madrid, 28049
About this study
Official title: Study to Evaluate the Usability of PointCheck, a Novel Optical Technology for Screening Non-Invasively Severe Neutropenia
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.
- Conditions
- Neoplasms, Chemotherapy-induced Neutropenia
- Being tested
- PointCheck
- Keywords
- Medical Device, Technology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PointCheckDiagnostic test
This is a usability study on PointCheck, a new technology to detect chemotherapy-induced neutropenia
What is being measured
The primary outcome is the main question the study is designed to answer.
PointCheck's Usability
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.
Measured: Up to three-weeks
System Usability Scale (0-100 higher scores indicate better usability)
To confirm the usability of the system using the System Usability Scale
Measured: Up to three-weeks
Secondary outcomes (4)
PointCheck's Precision
To perform an exploratory analysis of the percentage agreement of PointCheck's estimation of WBC from two independent one-minute videos.
Measured: Up to three-weeks
PointCheck's Accuracy
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.
Measured: Up to three-weeks
PointCheck's Utility
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.
Measured: Up to three-weeks
PointCheck's Safety: total number (%) of AEs and SAEs
The number (and %) of AEs, SAEs and their relationship with the device use will be the safety endpoint
Measured: Up to three-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start11 Feb 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leuko Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joaquin Martinez López, MD, Principal investigator, Fundación de Investigación del Hospital 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448314
- Sponsor's protocol ID
- PC001-EU
- Status last verified
- Mar 2023
- First submitted
- 10 Jun 2020
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35943786
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Usability of PointCheck, a Novel Optical Technology for Screening Non-Invasively Severe Neutropenia
- ClinicalTrials.gov ID
- NCT04448314
- Acronym / sponsor ID
- PC001-EU
- Conditions
- Neoplasms, Chemotherapy-induced Neutropenia
- Keywords
- Medical Device, Technology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Leuko Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PointCheckThis is a usability study on PointCheck, a new technology to detect chemotherapy-induced neutropenia | Diagnostic test | – |
Primary outcome
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.
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
4 secondary outcomes
PointCheck's Precision
Time frame: Up to three-weeks
PointCheck's Accuracy
Time frame: Up to three-weeks
PointCheck's Utility
Time frame: Up to three-weeks
PointCheck's Safety: total number (%) of AEs and SAEs
Time frame: Up to three-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Derived from this study: PubMed 35943786Lamaj 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joaquin Martinez López, MD principal investigator
Fundación de Investigación del Hospital 12 de Octubre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Chemotherapy-induced Neutropenia, run by Leuko Labs, Inc. at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PointCheck's Usability (time frame: Up to three-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04448314, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.