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RECRUITING
NCT06193239
PHASE2

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

Sponsor: Owlstone Ltd

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

45 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2023-10-05

Completion Date

2025-04-30

Last Updated

2024-10-15

Healthy Volunteers

No

Conditions

Interventions

DIAGNOSTIC_TEST

OWL-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