Capillary Blood Accuracy
CAPYBARA
2 other identifiers
observational
180
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2024
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2024
CompletedFirst Posted
Study publicly available on registry
August 9, 2024
CompletedStudy Start
First participant enrolled
November 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 3, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 3, 2025
CompletedAugust 9, 2024
August 1, 2024
12 months
July 31, 2024
August 5, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Validity of of the Liberty System for haematological parameters of interest: Hb, WBC, PLT, ANC
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.
Through study completion, up to 8 days per participant.
Reliability of of the Liberty System for haematological parameters of interest: Hb, WBC, PLT, ANC
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.
Through study completion, up to 8 days per participant.
Study Arms (3)
Phase 1
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
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.
Phase 3
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.
Interventions
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.
Eligibility Criteria
Adults with a diagnosis of solid tumour cancer who are undergoing systemic anti-cancer therapy (SACT).
You may qualify if:
- 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
- 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
You may not qualify if:
- History or current diagnosis of haematological malignancy
- Inadequate use and understanding of the English language, requiring a translator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Entia Ltdlead
MeSH Terms
Conditions
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2024
First Posted
August 9, 2024
Study Start
November 4, 2024
Primary Completion
November 3, 2025
Study Completion
November 3, 2025
Last Updated
August 9, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share