Affinity: Hospital Trial

Completed

• Conditions: Cancer
• Interventions: Diagnostic Test: Capillary finger prick blood sample

• Registration Number: NCT04211727
• Lead Sponsor: Entia Ltd

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.

Study Timeline

• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2019-12-23
• Study First Posted: 2019-12-26
• Study Start: 2020-10-26
• Primary Completion: 2022-01-17
• Study Completion: 2022-01-17
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 247

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 2	Capillary finger prick blood sample	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.
Cohort 1	Capillary finger prick blood sample	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Assessment and feedback	1 year	To measure the severity of each issue when the prototype device is used by healthcare professionals (Cohort 1) and participants (Cohort 2).

Trial Locations

Locations (1)

The Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom