Capillary Blood Accuracy

Not yet recruiting

• Conditions: Cancer
• Interventions: Device: Entia Liberty System

• Registration Number: NCT06544070
• Lead Sponsor: Entia Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-31
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-05
• Last Update Submitted: 2024-08-05
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Study Start: 2024-11-04
• Primary Completion: 2025-11-03
• Study Completion: 2025-11-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Phase 3	Entia Liberty System	Participants who are undergoing a routine venous draw as part of the standard of care as part of SACT toxicity monitoring. Participants will donate up to 3 finger prick samples to be tested on the Liberty device in a single session.
Phase 1	Entia Liberty System	Participants who have undergone a laboratory FBC test that has returned a neutrophil count of ≤ 1.0 x109/L who can be consented within 24 hours of the result. Participants will donate one finger prick sample up to once per day to be tested on the Liberty device.
Phase 2	Entia Liberty System	Participants who have undergone a laboratory FBC test that has returned a neutrophil count of ≤ 1.5 x109/L who can be consented within 24 hours of the result. Participants will donate up to 3 finger prick samples to be tested on the Liberty device in a single session.

Primary Outcome Measures

Name	Time	Method
Validity of of the Liberty System for haematological parameters of interest: Hb, WBC, PLT, ANC	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	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.