CancerNCT05025124
Entia Liberty: Accuracy and Precision
An observational study of Cancer, run by Entia Ltd at 1 site in United Kingdom.
Trial summary
This study forms part of Entia's clinical evidence for regulatory submission. This study evaluates Entia Liberty's performance claims with venous blood compared to the gold standard clinical laboratory haematology analysers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Entia Liberty
- Type of treatment
- Medical device
- How many people
- 530 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Oct 2022to 14 Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: No participants will be recruited. Samples used are from excess venous bloods from the Christie haematology laboratory
Who may be able to join
- Age >18 years old
- 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
- Blood samples that have been stored in K2-EDTA vacutainers only
- For Accuracy testing: Samples covering 75% of parameter ranges (Neutrophils: 0.5-7.5 x 109/L, Platelets: 20-450 x 109/L, Haemoglobin: 70-180 g/L), These will be determined by a gold standard analyser which has been recently calibrated.
- Reliability study: Level range per parameter. These will be determined by a gold standard analyser which has been recently calibrated.
- Neutrophils (We assume WBC to behave similarly in the same ranges) Low: 0.5-1.2 x 109/L (3 samples), 1.2-2 x 109/L (2 samples) Normal: 2-7 x 109/L (3-4 samples) High: 7-12 x 109/L (1-2 samples)
- Platelets Low: 50-150 x 109/L (5 samples) Normal: 150-400 x 109/L (3 - 4 samples) High: >400 x 109/L (1-2 samples)
- Haemoglobin Low: <120 g/L (5 samples) Normal: 120-170 g/L (3 - 4 samples) High: >170 g/L (1-2 samples)
Who cannot join
- History of haematological malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Entia Liberty: Analytical Performance Validation - Accuracy and Precision
This study forms part of Entia's clinical evidence for regulatory submission. This study evaluates Entia Liberty's performance claims with venous blood compared to the gold standard clinical laboratory haematology analysers. Excess blood flagged by the laboratory meeting our requirements will be tested on the Entia Liberty device and have its results compared against the laboratory results. Samples will also be flagged for precision testing (same blood sample, split into 10 Entia Liberty samples).
- Conditions
- Cancer
- Being tested
- Entia Liberty
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entia LibertyDevice
Home monitoring system
| Study group | Role | What they receive |
|---|---|---|
| Method comparison | 400 samples to be compared directly against the reference method. This is to get the bias estimate. Receives: Device: Entia Liberty | |
| Precision | 30 samples will be each split into 10 individual samples to evaluate the precision of the Entia Liberty devices. Receives: Device: Entia Liberty |
What is being measured
The primary outcome is the main question the study is designed to answer.
To obtain the Total Error per parameter from the results of the Entia Liberty device
The dataset from this study will provide evidence to support the device's performance claims.
Measured: 3 months
To obtain the linearity per parameter from the results of the Entia Liberty device
The dataset from this study will provide evidence to support the device's performance claims.
Measured: 3 months
To obtain the bias per parameter from the results of the Entia Liberty device
The dataset from this study will provide evidence to support the device's performance claims.
Measured: 3 months
To obtain the precision per parameter from the results of the Entia Liberty device
The dataset from this study will provide evidence to support the device's performance claims.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start3 Oct 2022
- Primary completion14 Dec 2022
- Study completion14 Dec 2022
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
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entia Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025124
- Sponsor's protocol ID
- 304727
- Status last verified
- Jan 2023
- First submitted
- 26 Aug 2021
- Last updated
- 27 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Entia Liberty: Analytical Performance Validation - Accuracy and Precision
- ClinicalTrials.gov ID
- NCT05025124
- Acronym / sponsor ID
- 304727
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- Entia LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 27 Aug 2021 (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 forms part of Entia's clinical evidence for regulatory submission. This study evaluates Entia Liberty's performance claims with venous blood compared to the gold standard clinical laboratory haematology analysers. Excess blood flagged by the laboratory meeting our requirements will be tested on the Entia Liberty device and have its results compared against the laboratory results. Samples will also be flagged for precision testing (same blood sample, split into 10 Entia Liberty samples).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Method comparison | – | Device: Entia Liberty400 samples to be compared directly against the reference method. This is to get the bias estimate. |
| Precision | – | Device: Entia Liberty30 samples will be each split into 10 individual samples to evaluate the precision of the Entia Liberty devices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- No participants will be recruited. Samples used are from excess venous bloods from the Christie haematology laboratory
Key inclusion criteria (8 listed)
- Age >18 years old
- 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
- Blood samples that have been stored in K2-EDTA vacutainers only
- For Accuracy testing: Samples covering 75% of parameter ranges (Neutrophils: 0.5-7.5 x 109/L, Platelets: 20-450 x 109/L, Haemoglobin: 70-180 g/L), These will be determined by a gold standard analyser which has been recently calibrated.
- Reliability study: Level range per parameter. These will be determined by a gold standard analyser which has been recently calibrated.
Key exclusion criteria (1 listed)
- History of haematological malignancy
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 LibertyHome monitoring system | Device | Method comparison, Precision |
Primary outcome
To obtain the Total Error per parameter from the results of the Entia Liberty device
Time frame: 3 months
The dataset from this study will provide evidence to support the device's performance claims.
To obtain the linearity per parameter from the results of the Entia Liberty device
Time frame: 3 months
The dataset from this study will provide evidence to support the device's performance claims.
To obtain the bias per parameter from the results of the Entia Liberty device
Time frame: 3 months
The dataset from this study will provide evidence to support the device's performance claims.
To obtain the precision per parameter from the results of the Entia Liberty device
Time frame: 3 months
The dataset from this study will provide evidence to support the device's performance claims.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Entia Ltd at 1 site 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?
The sponsor lists 8 inclusion and 1 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: finished, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 obtain the Total Error per parameter from the results of the Entia Liberty device (time frame: 3 months). The study lists 4 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 27 Jan 2023.