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Trial Title:
Capillary Blood Accuracy
NCT ID:
NCT06544070
Condition:
Cancer
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Device
Intervention name:
Entia Liberty System
Description:
Participants will donate finger-prick blood samples to be tested on the Entia Liberty
System. The results will not be used to inform clinical decisions or affect routine
clinical care in any way.
Arm group label:
Phase 1
Arm group label:
Phase 2
Arm group label:
Phase 3
Summary:
Entia is a health technology company that has developed a blood testing device called
Entia Liberty, which analyses blood collected by a finger prick. Entia is sponsoring this
research study to compare the results from Entia Liberty finger prick tests to results
from the gold-standard laboratory analyser that tests blood from the arm, port, or PICC
line.
Criteria for eligibility:
Study pop:
Adults with a diagnosis of solid tumour cancer who are undergoing systemic anti-cancer
therapy (SACT).
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Age ≥ 18 years old at the time of study entry
- Patients undergoing systemic anti-cancer therapy (SACT)
- Patients capable of providing written informed consent
- Patients undergoing routine Full Blood Count (FBC) laboratory blood tests as part of
the standard of care
Additional inclusion criteria:
- Phase 1 (Longitudinal, low count data): Neutrophil Count ≤ 1.0 x109/L within 24
hours preceding consenting
- Phase 2 (Low count data): Neutrophil Count ≤ 1.5 x109/L within 24 hours preceding
consenting
Exclusion Criteria:
- History or current diagnosis of haematological malignancy
- Inadequate use and understanding of the English language, requiring a translator
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 4, 2024
Completion date:
November 3, 2025
Lead sponsor:
Agency:
Entia Ltd
Agency class:
Industry
Source:
Entia Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06544070
