Affinity: Hospital Trial

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

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)

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Diagnostic test: Capillary finger prick blood sample

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 Type: Observational
• Enrollment (Actual): 247

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom
    • The Christie NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing systemic anti-cancer therapy (SACT)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; 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; Patients will have a blood finger prick sample
Cohort 2; 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; Patients will have a blood finger prick sample

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Entia Ltd
• Collaborators: The Christie NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2020
• Primary Completion (Actual): January 17, 2022
• Study Completion (Actual): January 17, 2022

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: December 23, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Oncology
• Other Study ID Numbers: IRAS ID 275879

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No