PC001- A Study to Evaluate the Usability of PointCheck

NCT ID: NCT04448301

Last Updated: 2025-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-09
• Study Completion Date: 2025-06-30

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

Conditions

Neoplasms; Neutropenia

Keywords

Medical Device; Technology; Non-invasive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PointCheck Cohort

Group Type: EXPERIMENTAL

PointCheck

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

PointCheck

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Leuko Labs, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Sloan, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35943786 (View on PubMed)

Other Identifiers

H-39964

Identifier Type: -

Identifier Source: org_study_id