Capillary Blood Accuracy (CAPYBARA)

Entia

Status: Not yet enrolling

Conditions: Cancer

Treatments: Device: Entia Liberty System

Study type: Observational

Funder types: Industry

Identifiers

NCT06544070

347665 (Other Identifier)

CTM-PRO-00028

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

180 participants in 3 patient groups

Phase 1

Description:

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.

Treatment:

Device: Entia Liberty System

Phase 2

Description:

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.

Treatment:

Device: Entia Liberty System

Phase 3

Description:

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.

Treatment:

Device: Entia Liberty System