RecruitingPhase 2NCT06193239

Diagnostic Accuracy Study for OWL-EVO1 As a Lung Cancer EVOC® Probe (Evolution Phase 2)

Diagnostic Accuracy Study for OWL-EVO1 As a Lung Cancer EVOC® Probe


Sponsor

Owlstone Ltd

Enrollment

350 participants

Start Date

Oct 5, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The Phase 2a Evolution study aims to assess the diagnostic accuracy of the OWL-EV1 Probe Breath Biopsy Test to differentiate between individuals with lung cancer and relevant contrast groups. The contrast groups will be representative of the clinical populations in which the test is intended to be used. Thus, Evolution Phase 2a will be designed as a cross-sectional, case-control trial that will be conducted at various sites, both in the UK and EU.


Eligibility

Min Age: 45 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new breath test device (OWL-EVO1) that analyzes exhaled breath compounds to see if it can accurately detect lung cancer. **You may be eligible if...** - You are between 45 and 85 years old - You have had a CT scan of the chest in the last 6 months - Your BMI is between 16 and 40 - You are able to provide written informed consent **You may NOT be eligible if...** - You cannot breathe adequately on your own during the breath test (e.g., severe respiratory disease) - You have been in another clinical drug trial in the past 28 days - You have an inconclusive or indeterminate lung nodule on CT scan that is still under monitoring - You have had prior lung surgery beyond simple biopsy procedures - You have another cancer being investigated that hasn't been diagnosed yet Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTOWL-EVO1

EVOC probe


Locations(9)

Thomayer Hospital

Prague, Prague, Czechia

National Koranyi Institute for Pulmonology

Budapest, Budapest, Hungary

Department of Pulmonology, University of Debrecen

Debrecen, Debrecen, Hungary

Royal Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, United Kingdom

Wythenshawe Hospital

Manchester, Greater Manchester, United Kingdom

Glenfield Hospital

Leicester, Leicestershire, United Kingdom

Barts Health NHS Trust

London, London, United Kingdom

Imperial Centre for Translational and Experimental Medicine, Imperial College

London, London, United Kingdom

Quadram Institute

Norwich, Norfolk, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06193239


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