Capillary-Venous Paired Collection (CaVe)

May 28, 2026 updated by: Entia Ltd

CApillary-VEnous Paired Collection (CAVE)

This study is recruiting participants to donate 3 capillary blood samples to be tested on the investigational system. At the same time, remnant routine blood samples used for Complete Blood Count (CBC) testing from the same participants will be tested on the investigation system. The participants' CBC results analyzed on the gold standard laboratory analyzer (comparator) will be collected and compared against the results obtained from the testing of capillary blood samples and remnant blood samples on the investigational system. The participants' involvement in the study is only for the duration of collecting the blood samples. No follow-up is anticipated. The results from the investigational system is for research use only and will not inform or change the participants' treatment or care.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Fife
      • Dunfermline, Fife, United Kingdom, KY12 0SU
        • Queen Margaret Hospital
    • Wrexham County Borough
      • Wrexham, Wrexham County Borough, United Kingdom, LL13 7YP
        • North Wales Clinical Research Facility
  • United States
    • Texas
      • Temple, Texas, United States, 76508
        • Baylor Scott & White - Temple

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Cancer patients undergoing treatment and attending clinic for Complete Blood Count (CBC) test

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
  • Scheduled to be undergoing routine CBC blood tests as part of standard of care
  • Can provide written informed consent
  • In the Investigator's opinion, is able and willing to comply with all study requirements

Exclusion Criteria:

  • History or current diagnosis of hematological malignancy (including bone and lymph)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants
All participants to undergo the same study method. Where all participants are to donate capillary blood to complete 2 tests on the investigational system and the remnant blood sample from routine CBC testing will also be tested on the investigational system. The routine CBC results will be compared to the results obtained by the investigational system.
Device: Entia Liberty System
See arm/group description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To validate the measurement performance of the investigational system (bias and %bias)
Time Frame: through study completion, estimated 6 months
The difference between the measured parameters of the comparator and investigational system will provide the bias (and therefore also the % bias) of the investigational system, which will be checked against pre-determined acceptance criteria.
through study completion, estimated 6 months
To validate the measurement performance of the investigational system (regression)
Time Frame: through study completion, estimated 6 months
The plotted difference between the measured parameters of the comparator and investigational system will provide the regression, which will be checked against pre-determined acceptance criteria.
through study completion, estimated 6 months
To validate the measurement performance of the investigational system (CV and SD)
Time Frame: through study completion, estimated 6 months
The difference between the measured parameters of the comparator and investigational system will inform the Coefficient of Variation and Standard Deviation of the dataset, which will be checked against pre-determined acceptance criteria.
through study completion, estimated 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Entia Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Actual)

December 27, 2023

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAVE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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