Status:
COMPLETED
PC001- A Study to Evaluate the Usability of PointCheck
Lead Sponsor:
Leuko Labs, Inc.
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Neoplasms
Neutropenia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 hem...
Eligibility Criteria
Inclusion
- 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.
- Male or Female aged 18 years or above.
- 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.
- Able (in the Investigators opinion) and willing to comply with all study requirements
- Exclusion Criteria
- Participants with amputations, congenital malformations, or any severe abnormalities of the hands as determined by the investigator.
- 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.
- Participants with circulating tumour cells in previous or current lab determinations.
- Participants with leukemia.
- Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor).
- Inadequately medically controlled hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmHg).
- Participants whose gold standard blood differential was obtained more than 120 minutes after the last evaluation with the medical device.
- 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.
- Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.
Exclusion
Key Trial Info
Start Date :
February 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT04448301
Start Date
February 9 2021
End Date
June 30 2025
Last Update
November 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Boston Medical Center
Boston, Massachusetts, United States, 02118