Actively Recruiting
Diagnostic Accuracy Study for OWL-EVO1 As a Lung Cancer EVOC® Probe (Evolution Phase 2)
Led by Owlstone Ltd · Updated on 2024-10-15
350
Participants Needed
9
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Diagnostic Accuracy Study for OWL-EVO1 As a Lung Cancer EVOC® Probe (Evolution Phase 2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 45 to 85 years
- Able to provide informed consent
- Body mass index (BMI) between 16 and less than 40
- Received a CT scan including the chest area within the last 6 months
You will not qualify if you...
- Unable or expected to be unable to complete the breath sampling procedure (e.g., difficulty breathing unaided or claustrophobia)
- Lacking mental capacity as judged by the investigator
- Received an investigational medical product in a clinical trial within 28 days before the first probe dose or within 5 times the half-life of that product, whichever is longer
- Currently being investigated for a possible cancer other than lung cancer without a conclusive diagnosis
- Having an inconclusive lung abnormality on CT scan requiring monitoring rather than biopsy or treatment
- History of lung surgery or bronchial interventions other than biopsy, lavage, or brushings
- Pregnant or breastfeeding, or women of childbearing potential not using adequate contraception (must use contraception for 2 months after last dose)
- Under investigation for suspected lung cancer but unlikely to get a definitive tissue diagnosis before treatment (e.g., stereotactic radiotherapy without biopsy)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Thomayer Hospital
Prague, Prague, Czechia, 140 59
Actively Recruiting
2
National Koranyi Institute for Pulmonology
Budapest, Budapest, Hungary, H-1121
Not Yet Recruiting
3
Department of Pulmonology, University of Debrecen
Debrecen, Debrecen, Hungary, H-4032
Actively Recruiting
4
Royal Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB2 0AY
Actively Recruiting
5
Wythenshawe Hospital
Manchester, Greater Manchester, United Kingdom, M23 9LT
Actively Recruiting
6
Glenfield Hospital
Leicester, Leicestershire, United Kingdom, LE3 9QP
Actively Recruiting
7
Barts Health NHS Trust
London, London, United Kingdom, E1 1FR
Not Yet Recruiting
8
Imperial Centre for Translational and Experimental Medicine, Imperial College
London, London, United Kingdom, W12 0HS
Actively Recruiting
9
Quadram Institute
Norwich, Norfolk, United Kingdom, NR4 7UQ
Actively Recruiting
Research Team
L
Liz Thompson
CONTACT
A
Alice Michael
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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