CancerNCT04211727
Affinity: Hospital Trial
An observational study of Cancer, run by Entia Ltd at 1 site in United Kingdom.
Trial summary
Method comparison study to compare the Affinity prototype device using a capillary blood sample against routine venous laboratory results, in patients undergoing systemic anti-cancer therapy (SACT). Tests will be performed by healthcare professionals (Cohort 1) and participants self-testing (Cohort 2) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Capillary finger prick blood sample
- How many people
- 247 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Oct 2020to 17 Jan 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: Patients undergoing systemic anti-cancer therapy (SACT)
Who may be able to join
- Age >18 years old at the time of study entry Currently receiving standard of care systemic anti-cancer therapy for solid organ malignancy and has received at least one cycle
- Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care
- Can provide written informed consent
- Cohort 2 only- Able to independently complete participant questionnaires
Who cannot join
- Receiving systemic anti-cancer therapy for a haematological malignancy
- Known parasitic infection
- Known inherited or acquired bleeding disorder
- History of haematological malignancy
- Known poorly controlled anti-coagulation
- Cohort 2 only- Participant or carer unable or unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Affinity: Hospital Trial. Early Prototype Testing for a Home Oncology Monitoring System
Method comparison study to compare the Affinity prototype device using a capillary blood sample against routine venous laboratory results, in patients undergoing systemic anti-cancer therapy (SACT). Tests will be performed by healthcare professionals (Cohort 1) and participants self-testing (Cohort 2)
Read the detailed description
In this study the Investigators wish to compare 200 finger prick sample (capillary) blood results taken and analysed using the Affinity prototype device to standard of care venous blood samples, taken from the participant on the same day. The blood tests will analyse Full Blood Count (FBC)
200 patients will be recruited in total. 100 will take part in Cohort 1, where a member of the clinical research team will take their blood sample using the Affinity prototype device. The other 100 will take part in Cohort 2, where the participant will self test and take the blood sample themselves. Participants will be asked to complete a short questionnaire after using the device to provide any feedback on its design and use.
- Conditions
- Cancer
- Being tested
- Capillary finger prick blood sample
- Keywords
- Oncology, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capillary finger prick blood sampleDiagnostic test
Patients will have a blood finger prick sample
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Patients receiving standard of care systemic anti-cancer therapy for solid organ malignancy and has received at least one cycle aged 18 years and over. Receives: Diagnostic Test: Capillary finger prick blood sample | |
| Cohort 2 | Patients receiving standard of care systemic anti-cancer therapy for solid organ malignancy and has received at least one cycle aged 18 years and over. Receives: Diagnostic Test: Capillary finger prick blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the accuracy (bias) of the Affinity prototype device against laboratory testing (capillary vs. venous sample)
Measuring Full Blood Count (FBC)
Measured: 1 year
Secondary outcomes (2)
Assessment and feedback
To measure the number of issues when the prototype device is used by healthcare professionals (Cohort 1) and participants (Cohort 2).
Measured: 1 year
Assessment and feedback
To measure the severity of each issue when the prototype device is used by healthcare professionals (Cohort 1) and participants (Cohort 2).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start26 Oct 2020
- Primary completion17 Jan 2022
- Study completion17 Jan 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entia Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Christie NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211727
- Sponsor's protocol ID
- IRAS ID 275879
- Status last verified
- Mar 2022
- First submitted
- 18 Dec 2019
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affinity: Hospital Trial. Early Prototype Testing for a Home Oncology Monitoring System
- ClinicalTrials.gov ID
- NCT04211727
- Acronym / sponsor ID
- IRAS ID 275879
- Conditions
- Cancer
- Keywords
- Oncology, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Entia LtdIndustry (pharma, biotech, devices)
- Collaborators
- The Christie NHS Foundation Trust
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 17 Jan 2022 (actual)
- First posted
- 26 Dec 2019 (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.
Method comparison study to compare the Affinity prototype device using a capillary blood sample against routine venous laboratory results, in patients undergoing systemic anti-cancer therapy (SACT). Tests will be performed by healthcare professionals (Cohort 1) and participants self-testing (Cohort 2)
Detailed description
In this study the Investigators wish to compare 200 finger prick sample (capillary) blood results taken and analysed using the Affinity prototype device to standard of care venous blood samples, taken from the participant on the same day. The blood tests will analyse Full Blood Count (FBC)
200 patients will be recruited in total. 100 will take part in Cohort 1, where a member of the clinical research team will take their blood sample using the Affinity prototype device. The other 100 will take part in Cohort 2, where the participant will self test and take the blood sample themselves. Participants will be asked to complete a short questionnaire after using the device to provide any feedback on its design and use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Diagnostic Test: Capillary finger prick blood samplePatients receiving standard of care systemic anti-cancer therapy for solid organ malignancy and has received at least one cycle aged 18 years and over. |
| Cohort 2 | – | Diagnostic Test: Capillary finger prick blood samplePatients receiving standard of care systemic anti-cancer therapy for solid organ malignancy and has received at least one cycle aged 18 years and over. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing systemic anti-cancer therapy (SACT)
Key inclusion criteria (4 listed)
- Age >18 years old at the time of study entry Currently receiving standard of care systemic anti-cancer therapy for solid organ malignancy and has received at least one cycle
- Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care
- Can provide written informed consent
- Cohort 2 only- Able to independently complete participant questionnaires
Key exclusion criteria (6 listed)
- Receiving systemic anti-cancer therapy for a haematological malignancy
- Known parasitic infection
- Known inherited or acquired bleeding disorder
- History of haematological malignancy
- Known poorly controlled anti-coagulation
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 |
|---|---|---|
| Capillary finger prick blood samplePatients will have a blood finger prick sample | Diagnostic test | Cohort 1, Cohort 2 |
Primary outcome
To assess the accuracy (bias) of the Affinity prototype device against laboratory testing (capillary vs. venous sample)
Time frame: 1 year
Measuring Full Blood Count (FBC)
2 secondary outcomes
Assessment and feedback
Time frame: 1 year
Assessment and feedback
Time frame: 1 year
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 29 Mar 2022.
- Individual participant dataSharing planned: No
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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 4 inclusion and 6 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 29 Mar 2022. 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 assess the accuracy (bias) of the Affinity prototype device against laboratory testing (capillary vs. venous sample) (time frame: 1 year). 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 Mar 2022; AzTrials last refreshed its copy on 29 Oct 2026.