Affinity: Hospital Trial
1 other identifier
observational
247
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2019
CompletedFirst Posted
Study publicly available on registry
December 26, 2019
CompletedStudy Start
First participant enrolled
October 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2022
CompletedMarch 29, 2022
March 1, 2022
1.2 years
December 18, 2019
March 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Assessment and feedback
1 year
Assessment and feedback
1 year
Study Arms (2)
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.
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.
Interventions
Patients will have a blood finger prick sample
Eligibility Criteria
Patients undergoing systemic anti-cancer therapy (SACT)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Entia Ltdlead
- The Christie NHS Foundation Trustcollaborator
Study Sites (1)
The Christie NHS Foundation Trust
Manchester, United Kingdom
MeSH Terms
Conditions
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2019
First Posted
December 26, 2019
Study Start
October 26, 2020
Primary Completion
January 17, 2022
Study Completion
January 17, 2022
Last Updated
March 29, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share