Capillary Blood Accuracy

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Entia Liberty System

Device

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.

Primary outcomes

Validity of of the Liberty System for haematological parameters of interest: Hb, WBC, PLT, ANC

Time frame: Through study completion, up to 8 days per participant.

The accuracy of the Liberty System will be measured by comparing the results of finger-prick blood samples that have been analysed using the Liberty System to the results of venous (blood from the arm, port or PICC line) blood samples that have been analysed by a standard laboratory haematology analyser.
Reliability of of the Liberty System for haematological parameters of interest: Hb, WBC, PLT, ANC

Time frame: Through study completion, up to 8 days per participant.

To measure the precision of the Liberty System by comparing the results of finger-prick blood samples that have been analysed by the Liberty System to each other, and to venous (blood from the arm, port or PICC line) blood samples that have been analysed by the Liberty System.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Rawlinson-Smith

CONTACT

[email protected]

02030200030

Madeline Lok

CONTACT

02030200030

Sponsors and collaborators

Lead sponsor

Entia Ltd

Industry

Registry information

Acronym: CAPYBARA

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Aug 9, 2024
Registry last updated: Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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