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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05926362
Other study ID # IRAS: 329382
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2023
Est. completion date September 1, 2026

Study information

Verified date June 2023
Source Entia Ltd
Contact Madeline Lok
Phone 020 3020 0030
Email madeline.lok@entia.co
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Capillary-venous paired data collection.


Description:

An iterative data collection study to continuously assess the performance of our Entia Liberty device with cancer patients. Our device enables a full blood count from a finger prick sample. The participants enrolled in the study will attend the study site for their routine venepuncture blood test. Once enrolled, they will have a finger prick test obtained by a Healthcare Professional (trained member of the clinical research team) to be tested on an Entia Liberty device. Within 4 hours of that same participant's routine venepuncture, a small amount of blood from the venepuncture will be also tested on a second Entia Liberty device in the laboratory. All the results from the capillary finger prick Liberty test, routine venepuncture blood test (gold standard reference method) and the venous blood Liberty test will be compared against each other to regularly assess that the improvements made on the measurement system of the device is sufficient.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 800
Est. completion date September 1, 2026
Est. primary completion date September 1, 2026
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 (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and has received at least one cycle of treatment - Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care - Can provide written informed consent Exclusion Criteria: - History of haematological malignancy - Inadequate use and understanding of the English language, requiring a translator

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Entia Ltd

Outcome

Type Measure Description Time frame Safety issue
Primary Coefficient of Variance of the difference between the lab results and the Liberty results the coefficient of variance (CV) between the lab results and the liberty results would be compared. a lower CV value signifies a better performance of our device. 3 years
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