NCT04211727

Affinity: Hospital Trial

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 247 (actual)
• Sponsor: Entia Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Capillary finger prick blood sample	Patients will have a blood finger prick sample

Timeline

• Start date: 2020-10-26
• Primary completion: 2022-01-17
• Completion: 2022-01-17
• First posted: 2019-12-26
• Last updated: 2022-03-29

Locations

1 site across 1 country: United Kingdom