Blood ClotsEVOLVENCT07378514
Cobas® Lumira Collection of Venous and Capillary Blood Samples for the Research, Optimization and Calibration of New Diagnostic Devices
An observational study of Blood Clots and Infection and Inflammatory Reaction, run by LumiraDx UK Limited.
Trial summary
This study is a blood sample collection study, collecting venous and capillary blood samples from adult patients in the UK, with a range of health conditions. The purpose of this study is to collect blood samples to help develop, improve, and fine-tune new and existing diagnostic tests for the cobas® lumira… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Blood Clots, Infection and Inflammatory Reaction, Heart Disease
- What is being tested?
- Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests
- How many people
- 30,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Jul 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: UK-based adults presenting to a study site and meeting the eligibility criteria. There are no demographic requirements for this study
Who may be able to join
- Willing and able to provide written informed consent.
- Willing to comply with study procedures.
- The participant must present as one of the following cohorts (primary presenting condition):
- Cohort A - Embolism Cohort (participants presenting with symptoms indicative of thromboembolic events)
- Cohort B - Infection or Inflammation Cohort (participants presenting with symptoms indicative of infection or inflammatory disorders)
- Cohort C - Cardiovascular Cohort (participants presenting with symptoms indicative of heart failure or acute coronary syndrome)
Show all 13Show fewer
- Cohort D - Renal Cohort (participants presenting with symptoms indicative of renal disorders)
- Cohort E - Oral Anticoagulation Cohort (participants with ongoing vitamin K antagonist therapy for at least four weeks)
- Cohort F - Diabetes Cohort (participants with suspected pre-Diabetes or diagnosed with Diabetes Mellitus Type 1 or Type 2)
- Cohort G - Lipid Cohort (participants presenting with symptoms indicative for Hypercholesterolemia )
- Cohort H - Liver Cohort (participants with symptoms indicative of hepatic disorders).
- 1. Participants ≥ 18 years of age
- 1. Participants ≥ 16 years old
Who cannot join
- Subjects deemed inappropriate for the study by the Principal Investigator.
- Participants who have previously been enrolled in the EVOLVE study in the past 60 days.
- Exclusion Criteria for Cohort E (Oral Anticoagulation Cohort):
- Subjects who are currently taking non-vitamin K antagonist oral anticoagulants (NOACs) including but not limited to apixaban, dabigatran etexilate, edoxaban and rivaroxaban.
- Subjects who have anti-phospholipid antibody syndrome (APS)
- The participant is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, experimental drug, or experimental device including either treatment or therapy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cobas® Lumira Collection of Venous and Capillary Blood Samples for the Research, Optimization and Calibration of New Diagnostic Devices (EVOLVE)
This study is a blood sample collection study, collecting venous and capillary blood samples from adult patients in the UK, with a range of health conditions. The purpose of this study is to collect blood samples to help develop, improve, and fine-tune new and existing diagnostic tests for the cobas® lumira instrument. This instrument is a diagnostic medical device with single-use test strips, that allows diagnostic testing right at the patient's side. The aim is to improve doctors' ability to monitor health conditions more quickly and easily.
Approximately 30,000 patients are expected to participate in this study, across multiple UK sites.
- Conditions
- Blood Clots, Infection and Inflammatory Reaction, Heart Disease, Kidney Disease, Vitamin K Antagonist, Diabetes
- Being tested
- Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests
- Medical subject headings
- Thrombosis, Infections, Inflammation, Heart Diseases, Kidney Diseases, Diabetes Mellitus, Hypercholesterolemia, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic testsDiagnostic test
Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests
| Study group | Role | What they receive |
|---|---|---|
| Blood clot | participants presenting with symptoms indicative of thromboembolic events Receives: Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests | |
| Infection/Inflammation | participants presenting with symptoms indicative of infection or inflammatory disorders Receives: Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests | |
| Heart disease | participants presenting with symptoms indicative of heart failure or acute coronary syndrome Receives: Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests | |
| Kidney disease | participants presenting with symptoms indicative of renal disorders Receives: Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests | |
| Blood thinners | participants with ongoing vitamin K antagonist therapy for at least four weeks Receives: Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests | |
| Diabetes | participants with suspected pre-Diabetes or diagnosed with Diabetes Mellitus Type 1 or Type 2 Receives: Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests | |
| High cholesterol | participants presenting with symptoms indicative of Hypercholesterolemia Receives: Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests | |
| Liver disease | participants with symptoms indicative of hepatic disorders Receives: Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker concentration
Blood samples will be used to take a quantitative baseline measurement of 1 or more biomarkers associated with the following health conditions:
- Thromboembolism
- Infection/Inflammation
- Cardiovascular disease
- Kidney disease
- Vitamin K antagonist therapy
- Diabetes
- Hypercholesterolemia
- Liver disease.
Measurements are used for research, development and calibration of point-of-care diagnostic tests, and may compare results between different test methods. There is no statistical analysis planned on these measurements.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2031 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood ClotsStudies 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
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LumiraDx UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378514
- Sponsor's protocol ID
- RD007454
- Acronym
- EVOLVE
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 30 Jan 2026
- 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 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cobas® Lumira Collection of Venous and Capillary Blood Samples for the Research, Optimization and Calibration of New Diagnostic Devices (EVOLVE)
- ClinicalTrials.gov ID
- NCT07378514
- Acronym / sponsor ID
- EVOLVE / RD007454
- Conditions
- Blood Clots, Infection and Inflammatory Reaction, Heart Disease, Kidney Disease, Vitamin K Antagonist, Diabetes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- LumiraDx UK LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 30 Jan 2026 (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 a blood sample collection study, collecting venous and capillary blood samples from adult patients in the UK, with a range of health conditions. The purpose of this study is to collect blood samples to help develop, improve, and fine-tune new and existing diagnostic tests for the cobas® lumira instrument. This instrument is a diagnostic medical device with single-use test strips, that allows diagnostic testing right at the patient's side. The aim is to improve doctors' ability to monitor health conditions more quickly and easily.
Approximately 30,000 patients are expected to participate in this study, across multiple UK sites.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Blood clot | – | Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic testsparticipants presenting with symptoms indicative of thromboembolic events |
| Infection/Inflammation | – | Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic testsparticipants presenting with symptoms indicative of infection or inflammatory disorders |
| Heart disease | – | Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic testsparticipants presenting with symptoms indicative of heart failure or acute coronary syndrome |
| Kidney disease | – | Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic testsparticipants presenting with symptoms indicative of renal disorders |
| Blood thinners | – | Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic testsparticipants with ongoing vitamin K antagonist therapy for at least four weeks |
| Diabetes | – | Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic testsparticipants with suspected pre-Diabetes or diagnosed with Diabetes Mellitus Type 1 or Type 2 |
| High cholesterol | – | Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic testsparticipants presenting with symptoms indicative of Hypercholesterolemia |
| Liver disease | – | Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic testsparticipants with symptoms indicative of hepatic disorders |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- UK-based adults presenting to a study site and meeting the eligibility criteria. There are no demographic requirements for this study
Key inclusion criteria (13 listed)
- Willing and able to provide written informed consent.
- Willing to comply with study procedures.
- The participant must present as one of the following cohorts (primary presenting condition):
- 1. Participants ≥ 18 years of age
- 1. Participants ≥ 16 years old
Key exclusion criteria (6 listed)
- Subjects deemed inappropriate for the study by the Principal Investigator.
- Participants who have previously been enrolled in the EVOLVE study in the past 60 days.
- Subjects who are currently taking non-vitamin K antagonist oral anticoagulants (NOACs) including but not limited to apixaban, dabigatran etexilate, edoxaban and rivaroxaban.
- Subjects who have anti-phospholipid antibody syndrome (APS)
- The participant is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, experimental drug, or experimental device including either treatment or therapy.
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 |
|---|---|---|
| Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic testsBlood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests | Diagnostic test | Blood clot, Blood thinners, Diabetes, Heart disease, High cholesterol, Infection/Inflammation, Kidney disease, Liver disease |
Primary outcome
Biomarker concentration
Time frame: Baseline
Blood samples will be used to take a quantitative baseline measurement of 1 or more biomarkers associated with the following health conditions: * Thromboembolism * Infection/Inflammation * Cardiovascular disease * Kidney disease * Vitamin K antagonist therapy * Diabetes * Hypercholesterolemia * Liver disease. Measurements are used for research, development and calibration of point-of-care diagnostic tests, and may compare results between different test methods. There is no statistical analysis planned on these measurements.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Clots and Infection and Inflammatory Reaction, run by LumiraDx UK Limited.
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 13 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: opening soon, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zoe Pounce, PhD (+44 1786 533 206, zoe.pounce@roche.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker concentration (time frame: Baseline). 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 30 Jan 2026.