OncologyCaVeP-DCNCT05926362
Capillary-Venous Paired Data Collection
An observational study of Oncology and Medical Devices, run by Entia Ltd at 2 sites in United Kingdom.
Trial summary
Capillary-venous paired data collection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oncology, Medical Devices, Healthy Subjects
- How many people
- 800 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 10 Feb 2025to 1 Sep 2028
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
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)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust
Aylesbury, Buckinghamshire, HP21 8AL
Wycombe Hospital, Buckinghamshire Healthcare NHS Trust
High Wycombe, Buckinghamshire, HP11 2TT
About this study
Capillary-venous paired data collection.
Read the 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.
- Conditions
- Oncology, Medical Devices, Healthy Subjects
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Bias (including %bias and absolute bias) between the lab results and the Liberty results
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.
Measured: 3 years
Regression between the lab results and the Liberty results
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
Measured: 3 years
Secondary outcomes (2)
Correlation between the Liberty results of different specimen types (capillary blood vs venous blood)
Regression, bias, CV between the Liberty results of the specimen types from the same participants to be compared for accuracy and precision.
Measured: 3 yaers
Correlation between the performance of Liberty device between cancer patients and healthy volunteers
Observe and evaluate the difference in performance (bias, regression, CV) of the Liberty device when used with cancer patients and healthy volunteers
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start10 Feb 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Why it stopped: Paused for interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Entia Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926362
- Sponsor's protocol ID
- IRAS: 329382
- Acronym
- CaVeP-DC
- Status last verified
- Jul 2026
- First submitted
- 22 May 2023
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not planned to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capillary-Venous Paired Data Collection
- ClinicalTrials.gov ID
- NCT05926362
- Acronym / sponsor ID
- CaVeP-DC / IRAS: 329382
- Conditions
- Oncology, Medical Devices, Healthy Subjects
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Paused for interim analysis
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Entia LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Capillary-venous paired data collection.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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
2 secondary outcomes
Correlation between the Liberty results of different specimen types (capillary blood vs venous blood)
Time frame: 3 yaers
Correlation between the performance of Liberty device between cancer patients and healthy volunteers
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No. It is not planned to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology and Medical Devices, run by Entia Ltd at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coefficient of Variance of the difference between the lab results and the Liberty results (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.