Capillary-Venous Paired Data Collection

Oncology Clinical Trial

— CaVeP-DC  

Official title:

Capillary-Venous Paired Data Collection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05926362
• Other study ID #: IRAS: 329382
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: September 1, 2026

Study information

• Verified date: June 2023
• Source: Entia Ltd
• Contact: Madeline Lok
• Phone: 020 3020 0030
• Email: madeline.lok[@]entia.co
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Capillary-venous paired data collection.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Oncology

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Entia Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coefficient of Variance of the difference between the lab results and the Liberty results	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.	3 years