Cancer
Conditions
Keywords
Oncology, Cancer
Brief summary
Method comparison study to compare the Affinity prototype device using a capillary blood sample against routine venous laboratory results, in patients undergoing systemic anti-cancer therapy (SACT). Tests will be performed by healthcare professionals (Cohort 1) and participants self-testing (Cohort 2)
Detailed description
In this study the Investigators wish to compare 200 finger prick sample (capillary) blood results taken and analysed using the Affinity prototype device to standard of care venous blood samples, taken from the participant on the same day. The blood tests will analyse Full Blood Count (FBC) 200 patients will be recruited in total. 100 will take part in Cohort 1, where a member of the clinical research team will take their blood sample using the Affinity prototype device. The other 100 will take part in Cohort 2, where the participant will self test and take the blood sample themselves. Participants will be asked to complete a short questionnaire after using the device to provide any feedback on its design and use.
Interventions
DIAGNOSTIC_TESTCapillary finger prick blood sample
Patients will have a blood finger prick sample
Sponsors
The Christie NHS Foundation Trust
Entia Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
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 Currently receiving standard of care systemic anti-cancer therapy for solid organ malignancy and has received at least one cycle * Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care * Can provide written informed consent * Cohort 2 only- Able to independently complete participant questionnaires
Exclusion criteria
* Receiving systemic anti-cancer therapy for a haematological malignancy * Known parasitic infection * Known inherited or acquired bleeding disorder * History of haematological malignancy * Known poorly controlled anti-coagulation * Cohort 2 only- Participant or carer unable or unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the accuracy (bias) of the Affinity prototype device against laboratory testing (capillary vs. venous sample) | 1 year | Measuring Full Blood Count (FBC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment and feedback | 1 year | To measure the number of issues when the prototype device is used by healthcare professionals (Cohort 1) and participants (Cohort 2). |
Countries
United Kingdom
Outcome results
None listed