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