Evaluating the usability of a non-invasive device for monitoring chemotherapy-induced neutropenia
PC001 - Study to Evaluate the Usability of PointCheck, a Novel Optical Technology for Screening Non-Invasively Severe Neutropenia
This study is testing a new non-invasive device called PointCheck to see if it can help cancer patients easily monitor their white blood cell levels during chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leuko Labs, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04448301 on ClinicalTrials.gov |
What this trial studies
This study evaluates the usability of PointCheck, a novel non-invasive technology designed to monitor chemotherapy-induced neutropenia in cancer patients. It will involve 90 oncologic outpatients receiving standard chemotherapy at an outpatient hematology clinic. Participants will be tested twice with PointCheck during the same session, and usability will also be assessed in a simulated at-home environment by naïve users. The study aims to gather preliminary data on the device's diagnostic accuracy and precision.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with hematological or breast cancer who are scheduled for chemotherapy with a high or intermediate risk of neutropenia.
Not a fit: Patients with severe hand abnormalities or certain rheumatologic conditions that affect microcirculation may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could provide a more accessible and user-friendly method for monitoring neutropenia in cancer patients undergoing chemotherapy.
How similar studies have performed: While this approach is innovative, similar studies evaluating non-invasive monitoring technologies have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Boston, Massachusetts
- Boston Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Mark Sloan, MD — Boston Medical Center
- Study coordinator: Álvaro Sánchez-Ferro, MD
- Email: alvaro@leuko.io
- Phone: +34619223086
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.