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NCT Number: NCT05926362

Capillary-Venous Paired Data Collection

Capillary-venous paired data collection.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Coefficient of Variance of the difference between the lab results and the Liberty results

    Time frame: 3 years

    the coefficient of variance (CV) between the lab results and the liberty results would be compared. a lower CV value signifies a better performance of our device.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Rawlinson-Smith

CONTACT

[email protected]

020 3020 0030

Madeline Lok

CONTACT

[email protected]

020 3020 0030

Sponsors and collaborators

Lead sponsor

Entia Ltd

Industry

Registry information

Acronym: CaVeP-DC

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2023
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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