Capillary-Venous Paired Data Collection (CaVeP-DC)

Capillary-venous paired data collection.

Study Overview

• Status: Not yet recruiting
• Conditions: Oncology

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Madeline Lok; Phone Number: 020 3020 0030; Email: madeline.lok@entia.co
• Study Contact Backup: Name: Hannah Rawlinson-Smith; Phone Number: 020 3020 0030; Email: hannah.rawlinson-smith@entia.co

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are currently receiving standard of care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and have received at least one cycle.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Entia Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: June 21, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: IRAS: 329382

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It is not planned to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No