Cancer
Conditions
Brief summary
Entia is a health technology company that has developed a blood testing device called Entia Liberty, which analyses blood collected by a finger prick. Entia is sponsoring this research study to compare the results from Entia Liberty finger prick tests to results from the gold-standard laboratory analyser that tests blood from the arm, port, or PICC line.
Interventions
DEVICEEntia Liberty System
Participants will donate finger-prick blood samples to be tested on the Entia Liberty System. The results will not be used to inform clinical decisions or affect routine clinical care in any way.
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
No
Inclusion criteria
* Age ≥ 18 years old at the time of study entry * Patients undergoing systemic anti-cancer therapy (SACT) * Patients capable of providing written informed consent * Patients undergoing routine Full Blood Count (FBC) laboratory blood tests as part of the standard of care Additional inclusion criteria: * Phase 1 (Longitudinal, low count data): Neutrophil Count ≤ 1.0 x109/L within 24 hours preceding consenting * Phase 2 (Low count data): Neutrophil Count ≤ 1.5 x109/L within 24 hours preceding consenting
Exclusion criteria
* History or current diagnosis of haematological malignancy * Inadequate use and understanding of the English language, requiring a translator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validity of of the Liberty System for haematological parameters of interest: Hb, WBC, PLT, ANC | Through study completion, up to 8 days per participant. | The accuracy of the Liberty System will be measured by comparing the results of finger-prick blood samples that have been analysed using the Liberty System to the results of venous (blood from the arm, port or PICC line) blood samples that have been analysed by a standard laboratory haematology analyser. |
| Reliability of of the Liberty System for haematological parameters of interest: Hb, WBC, PLT, ANC | Through study completion, up to 8 days per participant. | To measure the precision of the Liberty System by comparing the results of finger-prick blood samples that have been analysed by the Liberty System to each other, and to venous (blood from the arm, port or PICC line) blood samples that have been analysed by the Liberty System. |
Outcome results
None listed