PC001- A Study to Evaluate the Usability of PointCheck

Leuko Labs

Status: Enrolling

Conditions: Neutropenia; Neoplasms

Treatments: Diagnostic Test: PointCheck

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT04448301

H-39964

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

PointCheck Cohort

Experimental group

Treatment:

Diagnostic Test: PointCheck