NCT07378514Not yet recruiting
Cobas® Lumira Collection of Venous and Capillary Blood Samples for the Research, Optimization and Calibration of New Diagnostic Devices
Cobas® Lumira Collection of Venous and Capillary Blood Samples for the Research, Optimization and Calibration of New Diagnostic Devices (EVOLVE)
Source: ClinicalTrials.gov · Last updated 30 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 30000 (estimated)
- First submitted
- 14 Jan 2026
- Start date
- Apr 2026
- Primary completion date
- Apr 2031
- Lead sponsor
- LumiraDx UK Limited
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT07378514
What you commit to
- Study type: Observational
- Planned participants: 30000
- From Apr 2026 to the primary completion date, Apr 2031
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- Subjects who have anti-phospholipid antibody syndrome (APS)
Other
- Subjects deemed inappropriate for the study by the Principal Investigator.
Who the study is looking for
- 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)
- 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
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.