Capillary-Venous Paired Data Collection (CaVeP-DC)

July 28, 2026 updated by: Entia Ltd
Capillary-venous paired data collection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

An iterative data collection study to continuously assess the performance of our Entia Liberty device with cancer patients and healthy volunteers. 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
    • Buckinghamshire
      • Aylesbury, Buckinghamshire, United Kingdom, HP21 8AL
        • Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust
      • High Wycombe, Buckinghamshire, United Kingdom, HP11 2TT
        • Wycombe Hospital, Buckinghamshire Healthcare NHS Trust

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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 AND healthy volunteers.

Description

CANCER COHORT:

Subjects fulfilling all of the following inclusion criteria are eligible for the study:

  • 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 venous laboratory blood tests as part of the standard of care
  • Able to provide capillary whole blood donation from pricking three different fingers on one hand
  • Can provide written informed consent
  • In the Investigator's opinion, is able and willing to comply with all study requirements

The presence of any one of the following exclusion criteria will lead to the exclusion of the subject:

  • History or current diagnosis of haematological malignancy (including bone and lymph)
  • Inadequate use and understanding of the English language, requiring a translator

HEALTHY COHORT

Subjects fulfilling all of the following inclusion criteria are eligible for the study:

  • Age ≥18 years old at the time of study entry
  • Can provide written informed consent
  • Have an NHS number (to enable ordering and tracking of laboratory FBC tests)
  • Registered with a GP
  • In the Investigator's opinion, is able and willing to comply with all study requirements

The presence of any one of the following exclusion criteria will lead to the exclusion of the subject:

  • Inadequate use and understanding of the English language, requiring a translator
  • Been hospitalised within 90 days prior to their study visit
  • Donated whole blood or plasma to a blood bank within the 90 days prior to the study visit
  • History of vasovagal syncope following blood draw

  • History or current diagnosis of the following conditions:

    • Cancer
    • Cardiovascular disease
    • Chronic kidney disease or end-stage renal disease
    • Bleeding disorder (including but not limited to Immune Thrombocytopenia (ITP), hemophilia, von Willebrand disease (VWD))
    • Blood clotting disorder (including but not limited to thrombophilia, antiphospholipid syndrome)
    • G6PD deficiency
    • Inflammatory bowel disease
    • Myelodysplastic syndrome
    • Ebola
    • Tuberculosis
    • HIV
    • Hepatitis B or C
    • Current diagnosis of Epstein-Barr Virus or Cytomegalovirus
    • Current diagnosis of diabetes mellitus, unless controlled by diet alone OR participant has been taking the same dose of the same medication for 4 weeks or more and are feeling fit and well.
    • Undergone organ transplantation
    • Anemia, unless the participant is feeling fit and well (no dizziness, fatigue, shortness of breath etc)

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Cancer Cohort
This cohort are participants who are currently undergoing Systemic Anti-Cancer Treatment
Healthy Cohort
This cohort are participants who do not have any underlying conditions, to be used as a control group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 years
Bias (including %bias and absolute bias) between the lab results and the Liberty results
Time Frame: 3 years
Bias and absolute difference between the lab results and the liberty results would be compared. a lower bias signifies a better performance of our device.
3 years
Regression between the lab results and the Liberty results
Time Frame: 3 years
Regression between the lab results and the liberty results would be compared. a value closer to 1.00 signifies a better performance of the Liberty device
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation between the Liberty results of different specimen types (capillary blood vs venous blood)
Time Frame: 3 yaers
Regression, bias, CV between the Liberty results of the specimen types from the same participants to be compared for accuracy and precision.
3 yaers
Correlation between the performance of Liberty device between cancer patients and healthy volunteers
Time Frame: 3 years
Observe and evaluate the difference in performance (bias, regression, CV) of the Liberty device when used with cancer patients and healthy volunteers
3 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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