Capillary Blood Accuracy

NCT ID: NCT06544070

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-04

Study Completion Date

2025-11-03

Brief Summary

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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

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Conditions

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Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Entia Liberty System

Intervention Type 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.

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.

Entia Liberty System

Intervention Type 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.

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.

Entia Liberty System

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Entia Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Hannah Rawlinson-Smith

Role: CONTACT

02030200030

Madeline Lok

Role: CONTACT

02030200030

Other Identifiers

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347665

Identifier Type: OTHER

Identifier Source: secondary_id

CTM-PRO-00028

Identifier Type: -

Identifier Source: org_study_id

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