Clinical trial · Observational
Affinity: Hospital Trial
Affinity: Hospital Trial. Early Prototype Testing for a Home Oncology Monitoring System
NCT04211727CI-TRIAL-00057389completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capillary finger prick blood sample | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1
- description
- 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.
- interventionNames
- Diagnostic Test: Capillary finger prick blood sample
- label
- Cohort 2
- description
- 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.
- interventionNames
- Diagnostic Test: Capillary finger prick blood sample
Primary outcomes (1)
- measure
- To assess the accuracy (bias) of the Affinity prototype device against laboratory testing (capillary vs. venous sample)
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.