PC001- A Study to Evaluate the Usability of PointCheck

Launched by LEUKO LABS, INC. · Jun 24, 2020

Keywords

ClinConnect Summary

This clinical trial, called PC001, is studying a new technology called PointCheck, which is designed to help monitor a common side effect of chemotherapy called neutropenia. Neutropenia is when a patient has low levels of white blood cells, making them more vulnerable to infections. The trial will take place in an outpatient hematology clinic and aims to include 90 patients who are receiving chemotherapy for cancers like lymphoma, myeloma, or breast cancer.

To be eligible for this study, participants must be at least 18 years old, understand the study's purpose, and be willing to provide consent. They should also be undergoing chemotherapy that has a risk of causing neutropenia. During the study, participants will undergo two tests with PointCheck in one visit and will also be asked to use the technology in a home-like setting to see how user-friendly it is. This trial is currently recruiting participants, and it aims to gather important information about how well PointCheck works and how easy it is to use. If you or someone you know is interested, it's a great opportunity to help advance cancer care!

Gender

ALL

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.