Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
530 participants
OBSERVATIONAL
2022-10-03
2022-12-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Method comparison
400 samples to be compared directly against the reference method. This is to get the bias estimate.
Entia Liberty
Home monitoring system
Precision
30 samples will be each split into 10 individual samples to evaluate the precision of the Entia Liberty devices.
Entia Liberty
Home monitoring system
Interventions
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Entia Liberty
Home monitoring system
Eligibility Criteria
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Inclusion Criteria
* Currently receiving standard of care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and has received at least one cycle
* Blood samples that have been stored in K2-EDTA vacutainers only
* For Accuracy testing: Samples covering 75% of parameter ranges (Neutrophils: 0.5-7.5 x 109/L, Platelets: 20-450 x 109/L, Haemoglobin: 70-180 g/L), These will be determined by a gold standard analyser which has been recently calibrated.
* Reliability study: Level range per parameter. These will be determined by a gold standard analyser which has been recently calibrated.
* Neutrophils (We assume WBC to behave similarly in the same ranges) Low: 0.5-1.2 x 109/L (3 samples), 1.2-2 x 109/L (2 samples) Normal: 2-7 x 109/L (3-4 samples) High: 7-12 x 109/L (1-2 samples)
* Platelets Low: 50-150 x 109/L (5 samples) Normal: 150-400 x 109/L (3 - 4 samples) High: \>400 x 109/L (1-2 samples)
* Haemoglobin Low: \<120 g/L (5 samples) Normal: 120-170 g/L (3 - 4 samples) High: \>170 g/L (1-2 samples)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Entia Ltd
INDUSTRY
Responsible Party
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Locations
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Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Countries
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Other Identifiers
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304727
Identifier Type: -
Identifier Source: org_study_id
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