PointCheck for Low White Blood Cell Count

Overseen By Álvaro Sánchez-Ferro, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Leuko Labs, Inc.

Must be taking: Cytotoxic chemotherapy

Disqualifiers: Leukemia, Tremor, Hypotension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2-3 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Mark Sloan, MD

Principal Investigator

Boston Medical Center

Eligibility Criteria

This trial is for adults over 18 with hematological cancers or breast cancer, who are undergoing high/intermediate risk neutropenia-inducing chemotherapy. They must understand the study and consent to participate. Excluded are those with uncontrolled low blood pressure, significant hand tremors or abnormalities, circulating tumor cells in labs, leukemia, certain rheumatologic conditions affecting circulation, or any condition that may risk their safety or affect results.

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

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

Exclusion Criteria

Inadequately medically controlled hypotension (systolic blood pressure <90 and diastolic blood pressure < 60mmHg)

You have a condition that causes noticeable shaking, such as essential tremor, Parkinson's disease, or dystonic tremor.

You have significant hand deformities or abnormalities that were present since birth or caused by amputations.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are tested twice with PointCheck during the same session and usability in an at-home simulated environment is evaluated

2-3 weeks

1 visit (in-person), at-home simulation

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks

Treatment Details

Interventions

• PointCheck

Trial Overview The trial tests PointCheck's usability—a non-invasive tool for monitoring neutropenia caused by chemotherapy in cancer patients. It involves two PointCheck tests during a clinic visit and an at-home simulation test by users unfamiliar with the device. The study aims to assess both how easy it is to use and its diagnostic accuracy.

Participant Groups

Group I: PointCheck Cohort Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Leuko Labs, Inc.

Lead Sponsor

Trials

4

Recruited

450+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+