Status:
COMPLETED
Study to Evaluate the Usability of PointCheck
Lead Sponsor:
Leuko Labs, Inc.
Conditions:
Neoplasms
Chemotherapy-induced Neutropenia
Eligibility:
All Genders
18+ years
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 hema...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Study subjects must be 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 hematological malignancy (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 tumor cells in previous or current lab determinations.
- Unstable participants or participants with hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmHg).
- 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 11 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04448314
Start Date
February 11 2020
End Date
June 30 2023
Last Update
August 22 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitari Dexeus. Grupo Quirónsalud
Barcelona, Spain, 08028
2
Breast Unit. Oncology Department. 12 Octubre Hospital
Madrid, Spain, 28041
3
Hospital Universitario 12 de Octubre
Madrid, Spain, 28049