PointCheck for Low White Blood Cell Count

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Overseen ByÁlvaro Sánchez-Ferro, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Leuko Labs, Inc.
Must be taking: Cytotoxic chemotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests PointCheck, a new non-invasive device designed to help cancer patients manage low white blood cell counts caused by chemotherapy. The trial aims to assess the device's ease of use at home and its effectiveness. It seeks cancer patients, particularly those with conditions like lymphoma or breast cancer, who are undergoing chemotherapy with a high risk of reducing white blood cells. Participants will try PointCheck twice in one session and simulate home use. As an unphased trial, this study allows patients to contribute to innovative research that could enhance at-home care for cancer patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing a device, so you may not need to change your medication routine, but it's best to confirm with the study team.

What prior data suggests that PointCheck is safe for monitoring chemotherapy-induced neutropenia?

Research has shown that PointCheck is a non-invasive tool designed to detect low white blood cell counts, particularly those resulting from chemotherapy. This study primarily examines the ease of use of PointCheck. Safety data from similar non-invasive devices indicate they are generally well-tolerated, meaning users typically do not experience negative side effects.

Since PointCheck is a monitoring tool and not a drug, it does not introduce substances into the body, making adverse reactions unlikely. Most safety concerns would focus on the device's accuracy in measuring white blood cell counts. However, because this study does not involve administering a new medication, safety risks remain minimal.

Overall, as a non-invasive tool, PointCheck is expected to be safe for users. The study's main focus is on its ease of use and accuracy in measuring white blood cell levels.12345

Why are researchers excited about this trial?

PointCheck is unique because it's a non-invasive technique aimed at detecting low white blood cell counts using a simple finger scan. Unlike traditional methods that require blood samples and lab work, PointCheck offers rapid, on-the-spot results without the need for needles. Researchers are excited about this trial because it could lead to quicker diagnosis and monitoring, which is especially beneficial for patients who need frequent checks, like those undergoing chemotherapy. This could significantly improve patient comfort and streamline the process of managing conditions that affect white blood cell levels.

What evidence suggests that PointCheck is effective for monitoring low white blood cell count?

Research has shown that PointCheck, the investigational tool studied in this trial, holds promise for detecting low levels of certain white blood cells, known as neutropenia, in patients receiving chemotherapy. Studies have demonstrated that even first-time users can effectively use PointCheck at home, indicating the device's ease of use and reliability for checking white blood cell levels without drawing blood. Early results also suggest that PointCheck accurately identifies severe cases of neutropenia. These findings are encouraging for patients who require regular monitoring without frequent hospital visits.678910

Who Is on the Research Team?

MS

Mark Sloan, MD

Principal Investigator

Boston Medical Center

Are You a Good Fit for This Trial?

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
See 1 more

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.
See 6 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: PointCheck CohortExperimental Treatment1 Intervention

Find a Clinic Near You

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+

Citations

White blood cell differential counts in severely leukopenic ...We evaluated the efficacy of white blood cell (WBC) differential counts in severely leukopenic samples by the Hematoflow method and by automated hematology ...
Usability Evaluation of a Noninvasive Neutropenia ...We have shown that PointCheck, a novel technology for noninvasive, home-based neutropenia detection, can be safely and effectively operated by first-time users.
A Leukocyte Score to Improve Clinical Outcome ...A simple leukocyte score was created by adding up the points related to the white blood cell count: neutropenia (neutrophil count <1.5. 106/L), 1 point; severe ...
(PDF) Usability Evaluation of a Noninvasive Neutropenia ...These preliminary results show that PointCheck™ is a promising technology to aid in the detection of severe neutropenia in the home setting. These results need ...
Smartphone based non invasive real time white blood cell ...This study introduces a ubiquous White Blood Cell counting system, UbiWhite, a novel smartphone-based, non-invasive system for real-time WBC counting from ...
Low White Blood Cell Count (Leukopenia)Without enough white blood cells, including enough neutrophils, you're more vulnerable to developing infections. A white blood cell count that's less than 4,000 ...
Low White Blood Cell Count: Causes and SolutionsWhat is a dangerously low white blood cell count? Anything below 4,000 WBCs per microliter. And if your neutrophil count is below 500 cells per ...
What Does a Low White Blood Cell Count Mean?Low white blood cell count (leukopenia) signals an issue with the immune system's ability to ward off infections.
What about leukopenia?Leukopenia, or a low white blood cell count, requires immediate medical attention to determine the underlying cause and appropriate ...
Clinical consequences of a polygenic predisposition to benign ...A benign predisposition to lower WBC counts has been shown to be associated with an increased risk of a low WBC count due to a medication (i.e. drug-induced ...
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