Healthy Subjects, Medical Devices, Oncology
Conditions
Brief summary
Capillary-venous paired data collection.
Detailed description
An iterative data collection study to continuously assess the performance of our Entia Liberty device with cancer patients and healthy volunteers. Our device enables a full blood count from a finger prick sample. The participants enrolled in the study will attend the study site for their routine venepuncture blood test. Once enrolled, they will have a finger prick test obtained by a Healthcare Professional (trained member of the clinical research team) to be tested on an Entia Liberty device. Within 4 hours of that same participant's routine venepuncture, a small amount of blood from the venepuncture will be also tested on a second Entia Liberty device in the laboratory. All the results from the capillary finger prick Liberty test, routine venepuncture blood test (gold standard reference method) and the venous blood Liberty test will be compared against each other to regularly assess that the improvements made on the measurement system of the device is sufficient.
Interventions
None listed
Sponsors
Entia Ltd
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
CANCER COHORT: Subjects fulfilling all of the following inclusion criteria are eligible for the study: * Age ≥18 years old at the time of study entry * Currently receiving standard-of-care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy * Scheduled to be undergoing routine venous laboratory blood tests as part of the standard of care * Able to provide capillary whole blood donation from pricking three different fingers on one hand * Can provide written informed consent * In the Investigator's opinion, is able and willing to comply with all study requirements The presence of any one of the following
Exclusion criteria
will lead to the exclusion of the subject: * History or current diagnosis of haematological malignancy (including bone and lymph) * Inadequate use and understanding of the English language, requiring a translator HEALTHY COHORT Subjects fulfilling all of the following inclusion criteria are eligible for the study: * Age ≥18 years old at the time of study entry * Can provide written informed consent * Have an NHS number (to enable ordering and tracking of laboratory FBC tests) * Registered with a GP * In the Investigator's opinion, is able and willing to comply with all study requirements The presence of any one of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coefficient of Variance of the difference between the lab results and the Liberty results | 3 years | the coefficient of variance (CV) between the lab results and the liberty results would be compared. a lower CV value signifies a better performance of our device. |
| Bias (including %bias and absolute bias) between the lab results and the Liberty results | 3 years | Bias and absolute difference between the lab results and the liberty results would be compared. a lower bias signifies a better performance of our device. |
| Regression between the lab results and the Liberty results | 3 years | Regression between the lab results and the liberty results would be compared. a value closer to 1.00 signifies a better performance of the Liberty device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between the Liberty results of different specimen types (capillary blood vs venous blood) | 3 yaers | Regression, bias, CV between the Liberty results of the specimen types from the same participants to be compared for accuracy and precision. |
| Correlation between the performance of Liberty device between cancer patients and healthy volunteers | 3 years | Observe and evaluate the difference in performance (bias, regression, CV) of the Liberty device when used with cancer patients and healthy volunteers |
Countries
United Kingdom
Outcome results
None listed