Lung Cancer
Conditions
Brief summary
Diagnostic accuracy: Diagnostic accuracy will be reported using a Receiver Operator Characteristic (ROC) curve and Area Under the Curve (AUC), as well as negative predictive value (NPV), positive predictive value (PPV), Sensitivity and Specificity. Metrics will be reported for overall test performance at all timepoints as well as pre-defined subgroup analyses.
Detailed description
Optimised test: Locked down protocol for breath sampling through evaluation of method, sampling timepoints, posture and duration of breath samples and determination of OWL-EVO1 dose. This optimised test will then be used to assess the primary objective., Safety and tolerability: Refined understanding of safety and tolerability of OWL-EVO1 based on reported Adverse Events associated with probe administration
Interventions
None listed
Sponsors
Owlstone Medical Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy: Diagnostic accuracy will be reported using a Receiver Operator Characteristic (ROC) curve and Area Under the Curve (AUC), as well as negative predictive value (NPV), positive predictive value (PPV), Sensitivity and Specificity. Metrics will be reported for overall test performance at all timepoints as well as pre-defined subgroup analyses. | — |
Secondary
| Measure | Time frame |
|---|---|
| Optimised test: Locked down protocol for breath sampling through evaluation of method, sampling timepoints, posture and duration of breath samples and determination of OWL-EVO1 dose. This optimised test will then be used to assess the primary objective., Safety and tolerability: Refined understanding of safety and tolerability of OWL-EVO1 based on reported Adverse Events associated with probe administration | — |
Countries
Czechia, Hungary
Outcome results
None listed