At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- OWL-EVO1 (diagnostic test)
- How long the study runs
- Study runs about 19 months (dates as stated)
- About the drug or intervention
- OWL-EVO1 — diagnostic test: EVOC probe
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 45 Years to 85 Years
- Who
- All
- Number of participants
- 187
- Started
- 2023-10-05
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for lung cancer
- • Phase2 - 187 participants
- • 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
Who can take part?
- • Ages 45 Years to 85 Years
- • Diagnosed with lung cancer
Where?
- • Cambridge - Royal Papworth Hospital NHS Foundation Trust
- • Manchester - Wythenshawe Hospital
- • Leicester - Glenfield Hospital
- • London - Barts Health NHS Trust
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 45 Years - 85 Years
- Who can join: All genders
What the study is looking for
- ✓Aged 45-85 years.
- ✓Ability to provide agreement to take part.
- ✓BMI 16 - \<40.
- ✓Receiving a CT including the thoracic region, within the last 6 months.
Who cannot take part
- ✗(Anticipated) inability to complete the breath sampling procedure (e.g., inability to maintain adequate ventilation...
- ✗Potential subjects who in the opinion of the investigator lack mental capacity.
- ✗Individuals under diagnostic investigation for a potential cancer other than lung cancer that has not yet...
- ✗Individuals with an inconclusive lung abnormality (indeterminate lung nodule) on CT-scan requiring CT-based...
- ✗Pregnant or breastfeeding women and women of child-bearing potential not using adequate contraceptive methods...
See the full criteria
Where Is This Study? (6 UK sites)
Royal Papworth Hospital NHS Foundation Trust
Cambridge CB2 0AY, United Kingdom
Wythenshawe Hospital
Manchester M23 9LT, United Kingdom
Glenfield Hospital
Leicester LE3 9QP, United Kingdom
Barts Health NHS Trust
London E1 1FR, United Kingdom
Imperial Centre for Translational and Experimental Medicine, Imperial College
London W12 0HS, United Kingdom
Quadram Institute
Norwich NR4 7UQ, United Kingdom
