Affinity: Hospital Trial

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04211727
• Other study ID #: IRAS ID 275879
• Status: Completed
• Start date: October 26, 2020
• Est. completion date: January 17, 2022

Study information

• Verified date: March 2022
• Source: Entia Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: January 17, 2022
• Est. primary completion date: January 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Diagnostic Test:
• Capillary finger prick blood sample
Patients will have a blood finger prick sample

Locations

Country	Name	City	State
United Kingdom	The Christie NHS Foundation Trust	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Entia Ltd	The Christie NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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