Capillary-Venous Paired Data Collection

Not yet recruiting

• Conditions: Oncology

• Registration Number: NCT05926362
• Lead Sponsor: Entia Ltd

Brief Summary

Capillary-venous paired data collection.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-05-22
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-21
• Last Update Submitted: 2023-06-21
• Study First Posted: 2023-07-03
• Last Update Posted: 2023-07-03
• Study Start: 2023-09-01
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 800

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coefficient of Variance of the difference between the lab results and the Liberty results	3 years	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.