About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willing and able to provide written informed consent.
Willing to comply with study procedures.
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)
Disqualifiers
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)
Trial population
UK-based adults presenting to a study site and meeting the eligibility criteria. There are no demographic requirements for this study
Trial design
Case-only
Cross-sectional
Treatments tested in this trial
Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests
Diagnostic testBlood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests
Treatment groups
8
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
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.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: