Affinity: Hospital Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Affinity: Hospital Trial. Early Prototype Testing for a Home Oncology Monitoring System

Conditions
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Cancer

Intervention / Treatment
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* Diagnostic Test: Capillary finger prick blood sample


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Patients receiving standard of care systemic anti-cancer therapy for solid organ malignancy and has received at least one cycle aged 18 years and over. | Diagnostic Test: Capillary finger prick blood sample<br>* Patients will have a blood finger prick sample<br>|
| Cohort 2<br>Patients receiving standard of care systemic anti-cancer therapy for solid organ malignancy and has received at least one cycle aged 18 years and over. | Diagnostic Test: Capillary finger prick blood sample<br>* Patients will have a blood finger prick sample<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the accuracy (bias) of the Affinity prototype device against laboratory testing (capillary vs. venous sample) | Measuring Full Blood Count (FBC) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment and feedback | To measure the number of issues when the prototype device is used by healthcare professionals (Cohort 1) and participants (Cohort 2). | 1 year | 
| Assessment and feedback | To measure the severity of each issue when the prototype device is used by healthcare professionals (Cohort 1) and participants (Cohort 2). | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oncology, Cancer