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.
In Evolution Phase 1, Owlstone Medical demonstrated the safety and tolerability of their Exogenous Volatile Organic Compound (EVOC) Probe. This phase also demonstrated proof of mechanism for the cleavage of the EVOC Probe, D5-ethyl-βD-glucuronide (OWL-EVO1), into D5-ethanol which can be detected on breath. This makes OWL-EVO-1 a promising EVOC Probe for the detection of lung cancer. The Evolution Phase 2a study will evaluate the diagnostic accuracy of an OWL-EVO1 based breath test for the differentiation of those with histopathologically confirmed lung cancer and relevant contrast groups with a CT-proven absence of lung cancer. These contrast groups will include those with relevant comorbidities, to truly evaluate accuracy and the robustness of test performance. As a secondary objective, the study aims to define a test protocol that minimises healthcare worker effort, whilst maximising tolerability and diagnosed accuracy for the intended use setting. This phase intends to recruit up to 150 cases and 200 controls. Both cohorts will be administered the probe intravenously. Multiple breath samples will be collected for up to 180 minutes post-probe infusion, with the cumulative sampling time not exceeding 60 minutes. The study results will provide valuable insights into the expected test performance as well as optimisation of the test in a clinical pathway.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
350
EVOC probe
Thomayer Hospital
Prague, Prague, Czechia
RECRUITINGNational Koranyi Institute for Pulmonology
Budapest, Budapest, Hungary
NOT_YET_RECRUITINGDiagnostic accuracy
The primary endpoint is to assess the diagnostic accuracy of the OWL-EVO1 Breath Biopsy test to differentiate between individuals with lung cancer and contrast groups. This will be reported using a Receiver Operator Characteristic Curve, NPV, PPV, Sensitivity, Specificity \& Likelihood Ratio's. Metrics will be reported for overall test performance as well as pre-defined subgroup analyses.
Time frame: 12 months
Optimised test
To define a test protocol for breath sampling and the OWL-EVO-1 infusion that achieves the optimal balance between minimising healthcare worker effort, maximising tolerability, and optimising diagnostic accuracy for the intended use setting. This will be in terms of method, timing, posture and duration.
Time frame: 12 months
Safety and tolerability
To gain a refined understanding of the safety and tolerability of OWL-EVO1. This will be based on reported Adverse Events associated with probe administration.
Time frame: 12 months
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Department of Pulmonology, University of Debrecen
Debrecen, Debrecen, Hungary
Royal Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
RECRUITINGWythenshawe Hospital
Manchester, Greater Manchester, United Kingdom
RECRUITINGGlenfield Hospital
Leicester, Leicestershire, United Kingdom
RECRUITINGBarts Health NHS Trust
London, London, United Kingdom
NOT_YET_RECRUITINGImperial Centre for Translational and Experimental Medicine, Imperial College
London, London, United Kingdom
RECRUITINGQuadram Institute
Norwich, Norfolk, United Kingdom
RECRUITING