Capillary Blood Accuracy (CAPYBARA)

August 5, 2024 updated by: Entia Ltd
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Madeline Lok
  • Phone Number: 02030200030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults with a diagnosis of solid tumour cancer who are undergoing systemic anti-cancer therapy (SACT).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Entia Liberty System
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.
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.
Device: Entia Liberty System
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.
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.
Device: Entia Liberty System
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, up to 8 days per participant.
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.
Through study completion, up to 8 days per participant.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Entia Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 4, 2024

Primary Completion (Estimated)

November 3, 2025

Study Completion (Estimated)

November 3, 2025

Study Registration Dates

First Submitted

July 31, 2024

First Submitted That Met QC Criteria

August 5, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 5, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CTM-PRO-00028
  • 347665 (Other Identifier: IRAS ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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