NCT07378514

Brief 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 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
60mo left

Started Apr 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Jul 2031

First Submitted

Initial submission to the registry

January 14, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2031

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

January 14, 2026

Last Update Submit

January 22, 2026

Conditions

Blood ClotsInfection and Inflammatory ReactionHeart DiseaseKidney DiseaseVitamin K AntagonistDiabetesHigh CholesterolLiver Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Study Arms (8)

Blood clot

participants presenting with symptoms indicative of thromboembolic events

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

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

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

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

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

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

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

Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests

Interventions

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

Blood clotBlood thinnersDiabetesHeart diseaseHigh cholesterolInfection/InflammationKidney diseaseLiver disease

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

UK-based adults presenting to a study site and meeting the eligibility criteria. There are no demographic requirements for this study

You may qualify if:

  • 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).
  • \. Participants ≥ 18 years of age
  • \. Participants ≥ 16 years old

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood and/or plasma

MeSH Terms

Conditions

ThrombosisInfectionsInflammationHeart DiseasesKidney DiseasesDiabetes MellitusHypercholesterolemiaLiver Diseases

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersDigestive System Diseases

Central Study Contacts

Zoe Pounce, PhD

CONTACT

+44 1786 533 206zoe.pounce@roche.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2026

First Posted

January 30, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2031

Study Completion (Estimated)

July 1, 2031

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share