Cancer, Medical Device Performance
Conditions
Brief summary
This study is recruiting participants to donate 3 capillary blood samples to be tested on the investigational system and venous blood to be tested on a comparator system. At the some sites, additional venous blood samples from the same participants will be tested on the investigation system. The participants' CBC results analyzed on the gold standard laboratory analyzer (comparator) will be collected and compared against the results obtained from the testing of capillary blood samples and venous blood samples on the investigational system. At certain sites, the usability of the investigational system is observed to evaluate the usability of the system. The participants' involvement in the study is only for the duration of collecting the blood samples. No follow-up is anticipated. The results from the investigational system is for research use only and will not inform or change the participants' treatment or care.
Interventions
DEVICEEntia Liberty System
See arm/group description
Sponsors
Entia Ltd
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed Consent signed by the subject * Age ≥21 years old at the time of study entry * Currently receiving standard-of-care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and/or targeted therapy) for solid organ malignancy * Scheduled to be undergoing routine venous laboratory blood tests as part of the standard of care OR willing to undergo a research-specific venous draw to obtain a complete/full blood count (CBC/FBC)
Exclusion criteria
* History or current diagnosis of hematological malignancy (including bone and lymph) * Patients who self-report disabilities or issues with their eyesight, hearing or dexterity that they believe will preclude the use of Liberty, and who do not have a carer who can assist them. * Patients who have had prior experience using Liberty * Inadequate use and understanding of the English language, requiring a translator Carer eligibility: * Age ≥ 21 years old at the time of study entry * Can provide written informed consent * Do NOT self-report disabilities or issues with their eyesight, hearing or dexterity that they believe will preclude the use of Liberty * Have NOT had prior experience using Liberty * Adequate use and understanding of the English language; NOT requiring a translator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To validate the measurement performance of the investigational system | through study completion, estimated 6 months | The difference between the measured parameters of the comparator and investigational system will provide the bias (and therefore also the % bias) of the investigational system, which will be checked against pre-determined acceptance criteria. |
| To validate the measurement performance of the investigational system (regression) | through study completion, estimated 6 months | The plotted difference between the measured parameters of the comparator and investigational system will provide the regression, which will be checked against pre-determined acceptance criteria. |
| To validate the measurement performance of the investigational system (CV and SD) | through study completion, estimated 6 months | The difference between the measured parameters of the comparator and investigational system will inform the Coefficient of Variation and Standard Deviation of the dataset, which will be checked against pre-determined acceptance criteria. |
| To validate the usability of the Liberty Analyzer System in a simulated home environment | Through study completion. Estimated 6 months | Participant to complete a usability questionnaire following use of Liberty. Observer to complete usability checklist during participants' use of Liberty |
| To prove equivalence in the measurement performance between the sampling matrices | through study completion, estimated 6 months | Performance comparison (bias, %bias, regression, CV) between the testing matrices (capillary whole blood and venous whole blood) on Liberty. |
Countries
United Kingdom, United States
Outcome results
None listed