Lung Cancer Indicator Detection
- Conditions
- Lung Cancer
- Interventions
- Device: ReCIVA breath sampler
- Registration Number
- NCT02612532
- Lead Sponsor
- Owlstone Ltd
- Brief Summary
The Lung Cancer Indicator Detection (LuCID) study investigates the the diagnostic accuracy of FAIMS for diagnosis of lung cancer by analysis of exhaled Volatile Organic Compounds.
- Detailed Description
Rationale Approximately 75% of patients with lung cancer present with advanced disease. For those with stage 1 disease, the chance of cure is up to 70%. Therefore, diagnostics which may aid identification of those with early stage lung cancer will play an important role in future screening programs. Because all cancer cells are characterized by a change in their metabolism related to their uncontrolled growth, detection of the resulting metabolites may be a novel diagnostic tool for early stage lung cancer. Subsets of these metabolites are volatile and are exhaled as so-called volatile organic compounds (VOCs). Analysis of exhaled VOCs suggests they differ between patients with advanced lung cancer and healthy controls. The Lung Cancer Indicator Detection (LuCID) study aims to validate the use of a high-throughput breath analysis technique in a population of patients whom are clinically suspected of having lung cancer.
Methods LuCID is an international, multi-center case-control study. Patients referred by their GP or treating specialist for a diagnostic work-up for lung cancer will be invited to participate in the study. A maximum of two thousand five hundred patients whom consent to partake in this study will be asked to provide a breath sample prior to any diagnostic procedures. This is a non-invasive procedure that will require the patient to breath normally into a facemask to collect 2.5L of breath amounting to approximately 10 minutes of breathing. The resulting samples will be analyzed for VOCs by Gas Chromatography coupled to Mass Spectrometry and Gas Chromotography coupled to Field Assymetrical Ion Mobility Spectrometry. The resulting VOC profiles will be used to generate a diagnostic algorithm in order to try to differentiate between patients with and without lung cancer in the intention to diagnose population. This study will not interfere in any with the standard care offered at the clinical sites.
Outcomes The results of this study will provide detailed insights into the accuracy of the test for the detection of lung cancer in the intention to diagnose population. This will form the foundation for a subsequent study in a population at risk for the development of lung cancer. If sufficiently accurate for early stage disease, analysis of breath VOCs could help implement large-scale screening for lung cancer, significantly decreasing the morbidity and mortality of the disease.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2603
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LuCID ReCIVA breath sampler Standardised exhaled volatile organic compound collection by "ReCIVA" breath sampler (http://www.owlstonenanotech.com/medical/products/reciva) for analysis of volatile organic compounds by Lonestar (http://www.owlstonenanotech.com/medical/products/lonestar)
- Primary Outcome Measures
Name Time Method Area Under the Curve for the diagnostic algorithm for lung cancer with optimal point sensitivity, specificity negative and positive predictive values. 2 years Diagnostic accuracy of VOC analysis for Lung Cancer diagnosis based on pattern recognition analysis of raw VOC-spectra generated by Lonestar analysis of breath.
- Secondary Outcome Measures
Name Time Method Fraction of within group variability in exhaled VOCs explained by factors not primarily related to disease proces 2 years Assessment of potential parameters affecting exhaled VOCs other than lung cancer such as smoking, diet and co-morbidities
Identified exhaled biomarkers associated with tumor stage and size. 2 years Analysis of correlation between exhaled biomarkers and the type, stage and size of the pulmonary tumor.
Trial Locations
- Locations (17)
UZA University Hospital Antwerp
🇧🇪Antwerp, Belgium
UZG University Hospital Gent
🇧🇪Gent, Belgium
PapworthHospital
🇬🇧Cambridge, Cambridgeshire, United Kingdom
University College London
🇬🇧London, United Kingdom
University Hospital Leipzig
🇩🇪Leipzig, Germany
University Hospital Bari
🇮🇹Bari, Italy
University Hospital of Leicester
🇬🇧Leicester, United Kingdom
Wycombe
🇬🇧Buckingham, United Kingdom
University Hospital Aintree NHS Foundation Trust
🇬🇧Liverpool, United Kingdom
Watford Hospital NHS Trust
🇬🇧London, United Kingdom
University Hospital of South Manchester NHs Foundation Trust
🇬🇧Manchester, United Kingdom
Nottingham University Hospital NHS Trust
🇬🇧Nottingham, United Kingdom
Royal Stoke University Hospital NHS Trust
🇬🇧Stoke, United Kingdom
Peterborough and Stamford Hospital
🇬🇧Peterborough, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom
South Tyneside District Hospital
🇬🇧South Shields, United Kingdom
Wirral University Teaching Hospital NHS Foundation Trust
🇬🇧Upton, United Kingdom