Diffuse Large B Cell Lymphoma, Multiple Myeloma
Conditions
Brief summary
Pivotal study to validate the diagnostic performance of PointCheck, the first non invasive device to preliminary detect neutropenia in cancer patients receiving intermediate/high risk antineoplastic therapy.
Interventions
DIAGNOSTIC_TESTPointCheck
Binary classification of severe neutropenia
Sponsors
Leuko Labs, Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
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 10 years or above. * Diagnosed with either Diffuse Large B Cell Lymphoma or Multiple Myeloma. * Scheduled treatment with any antineoplastic therapy with an associated high/intermediate risk of neutropenia according to NCCN guidelines. * Able (in the investigator's 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 any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor). * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PointCheck Accuracy | Two weeks | The main primary endpoints for this study will be the sensitivity and specificity of PointCheckTM to detect grade IV neutropenia ac cording to the CTCAE V5 definition of severe neutropenia in a standard blood analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PointCheck Precision | Two-weeks | Repeatability and reproducibility will be assessed using the % positive/negative results of the test's classification compared to the gold standard after multiple measurements in different contexts. |
| PointCheck Usability | Two-weeks | Mean System Usability Score |
| PointCheck Errors | Two-weeks | Device related errors (number/type) |
| PointCheck Safety | Two-weeks | total number (and %) of AEs and SAEs related to the device use. |
Countries
Spain, United States
Contacts
PRINCIPAL_INVESTIGATORCarlos Castro Gonzalez, PhD
Leuko Labs
Outcome results
None listed