Cobas® Lumira Collection of Venous and Capillary Blood Samples for the Research, Optimization and Calibration of New Diagnostic Devices
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests.
- Who it may be relevant to
- Registry conditions: Blood Clots, Infection and Inflammatory Reaction, Heart Disease, Kidney Disease. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cobas® Lumira Collection of Venous and Capillary Blood Samples for the Research, Optimization and Calibration of New Diagnostic Devices (EVOLVE)
Overview
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.
Interventions
- Diagnostic test Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests
Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests
Primary outcome measures
- Biomarker concentration [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- 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).
Inclusion Criteria for Cohorts A, B, C, D, E, G, and H:
1\. Participants ≥ 18 years of age
Inclusion Criteria for Cohort F (Diabetes Cohort):
1\. Participants ≥ 16 years old
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07378514 · RD007454