CancerCaVeNCT06183151
Capillary-Venous Paired Collection
An observational study of Cancer and Medical Device Performance, run by Entia Ltd at 3 sites in 2 countries.
Trial summary
This study is recruiting participants to donate 3 capillary blood samples to be tested on the investigational system and venous blood to be tested on a comparator system. At the some sites, additional venous blood samples from the same participants will be tested on the investigation system. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cancer, Medical Device Performance
- What is being tested?
- Entia Liberty System
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 13 Aug 2025to 30 Dec 2026
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients undergoing SACT treatment
Who may be able to join
- Informed Consent signed by the subject
- Age ≥21 years old at the time of study entry
- Currently receiving standard-of-care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and/or targeted therapy) for solid organ malignancy
- Scheduled to be undergoing routine venous laboratory blood tests as part of the standard of care OR willing to undergo a research-specific venous draw to obtain a complete/full blood count (CBC/FBC)
Who cannot join
- History or current diagnosis of hematological malignancy (including bone and lymph)
- Patients who self-report disabilities or issues with their eyesight, hearing or dexterity that they believe will preclude the use of Liberty, and who do not have a carer who can assist them.
- Patients who have had prior experience using Liberty
- Inadequate use and understanding of the English language, requiring a translator
- Carer eligibility:
- Age ≥ 21 years old at the time of study entry
Show all 10Show fewer
- Can provide written informed consent
- Do NOT self-report disabilities or issues with their eyesight, hearing or dexterity that they believe will preclude the use of Liberty
- Have NOT had prior experience using Liberty
- Adequate use and understanding of the English language; NOT requiring a translator
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites
Queen Margaret Hospital
Dunfermline, Fife, KY12 0SU
North Wales Clinical Research Facility
Wrexham, Wrexham County Borough, LL13 7YP
About this study
Official title: CApillary-VEnous Paired Collection (CAVE)
This study is recruiting participants to donate 3 capillary blood samples to be tested on the investigational system and venous blood to be tested on a comparator system. At the some sites, additional venous blood samples 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 venous blood samples on the investigational system. At certain sites, the usability of the investigational system is observed to evaluate the usability of the 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.
- Conditions
- Cancer, Medical Device Performance
- Being tested
- Entia Liberty System
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entia Liberty SystemDevice
See arm/group description
| Study group | Role | What they receive |
|---|---|---|
| Participants | All participants to undergo the same study method. Where all participants are to donate capillary blood to complete 3 tests on the investigational system and a comparator venous sample for testing on a comparator system. For certain sites, an additional venous sample will also be tested on the investigational system. The venous CBC results from the comparator system will be compared to the results of both capillary and venous specimens obtained by the investigational system. Receives: Device: Entia Liberty System |
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the measurement performance of the investigational system
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.
Measured: through study completion, estimated 6 months
To validate the measurement performance of the investigational system (regression)
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.
Measured: through study completion, estimated 6 months
To validate the measurement performance of the investigational system (CV and SD)
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.
Measured: through study completion, estimated 6 months
To validate the usability of the Liberty Analyzer System in a simulated home environment
Participant to complete a usability questionnaire following use of Liberty. Observer to complete usability checklist during participants' use of Liberty
Measured: Through study completion. Estimated 6 months
To prove equivalence in the measurement performance between the sampling matrices
Performance comparison (bias, %bias, regression, CV) between the testing matrices (capillary whole blood and venous whole blood) on Liberty.
Measured: through study completion, estimated 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start13 Aug 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Why it stopped: Recruitment Paused for data review
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- 400 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
- NCT06183151
- Sponsor's protocol ID
- CAVE
- Acronym
- CaVe
- Status last verified
- Jul 2026
- First submitted
- 28 Nov 2023
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Collection (CAVE)
- ClinicalTrials.gov ID
- NCT06183151
- Acronym / sponsor ID
- CaVe / CAVE
- Conditions
- Cancer, Medical Device Performance
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Recruitment Paused for data review
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Entia LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 27 Dec 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.
This study is recruiting participants to donate 3 capillary blood samples to be tested on the investigational system and venous blood to be tested on a comparator system. At the some sites, additional venous blood samples 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 venous blood samples on the investigational system. At certain sites, the usability of the investigational system is observed to evaluate the usability of the 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Device: Entia Liberty SystemAll participants to undergo the same study method. Where all participants are to donate capillary blood to complete 3 tests on the investigational system and a comparator venous sample for testing on a comparator system. For certain sites, an additional venous sample will also be tested on the investigational system. The venous CBC results from the comparator system will be compared to the results of both capillary and venous specimens obtained by the investigational system. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients undergoing SACT treatment
Key inclusion criteria (4 listed)
- Informed Consent signed by the subject
- Age ≥21 years old at the time of study entry
- Currently receiving standard-of-care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and/or targeted therapy) for solid organ malignancy
- Scheduled to be undergoing routine venous laboratory blood tests as part of the standard of care OR willing to undergo a research-specific venous draw to obtain a complete/full blood count (CBC/FBC)
Key exclusion criteria (10 listed)
- History or current diagnosis of hematological malignancy (including bone and lymph)
- Patients who self-report disabilities or issues with their eyesight, hearing or dexterity that they believe will preclude the use of Liberty, and who do not have a carer who can assist them.
- Patients who have had prior experience using Liberty
- Inadequate use and understanding of the English language, requiring a translator
- Age ≥ 21 years old at the time of study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Entia Liberty SystemSee arm/group description | Device | Participants |
Primary outcome
To validate the measurement performance of the investigational system
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.
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.
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.
To validate the usability of the Liberty Analyzer System in a simulated home environment
Time frame: Through study completion. Estimated 6 months
Participant to complete a usability questionnaire following use of Liberty. Observer to complete usability checklist during participants' use of Liberty
To prove equivalence in the measurement performance between the sampling matrices
Time frame: through study completion, estimated 6 months
Performance comparison (bias, %bias, regression, CV) between the testing matrices (capillary whole blood and venous whole blood) on Liberty.
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.
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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Medical Device Performance, run by Entia Ltd at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. 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 3 sites in United Kingdom, United States. 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?
To validate the measurement performance of the investigational system (time frame: through study completion, estimated 6 months). The study lists 5 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.