Capillary-Venous Paired Data Collection (CaVeP-DC)

Entia

Status: Not yet enrolling

Conditions: Oncology

Study type: Observational

Funder types: Industry

Identifiers

NCT05926362

IRAS: 329382

Details and patient eligibility

About

Capillary-venous paired data collection.

Full description

An iterative data collection study to continuously assess the performance of our Entia Liberty device with cancer patients. Our device enables a full blood count from a finger prick sample. The participants enrolled in the study will attend the study site for their routine venepuncture blood test. Once enrolled, they will have a finger prick test obtained by a Healthcare Professional (trained member of the clinical research team) to be tested on an Entia Liberty device. Within 4 hours of that same participant's routine venepuncture, a small amount of blood from the venepuncture will be also tested on a second Entia Liberty device in the laboratory. All the results from the capillary finger prick Liberty test, routine venepuncture blood test (gold standard reference method) and the venous blood Liberty test will be compared against each other to regularly assess that the improvements made on the measurement system of the device is sufficient.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 years old at the time of study entry
• Currently receiving standard of care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and has received at least one cycle of treatment
• Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care
• Can provide written informed consent

Exclusion criteria

• History of haematological malignancy
• Inadequate use and understanding of the English language, requiring a translator