Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2603 participants
INTERVENTIONAL
2015-10-07
2022-12-22
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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LuCID
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)
ReCIVA breath sampler
Device developed for standardised collection of breath samples http://www.owlstonenanotech.com/medical/products/reciva
Interventions
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ReCIVA breath sampler
Device developed for standardised collection of breath samples http://www.owlstonenanotech.com/medical/products/reciva
Eligibility Criteria
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Inclusion Criteria
* Referred for investigation due to suspicion of lung cancer
* Referral based on suspicious symptoms
* Referral based on suspicious finding on imaging, including CTscan with indeterminate nodule requiring follow-up evaluation.
* Capable of understanding written and/or spoken language
* Able to provide informed consent
Exclusion Criteria
* Participating in a Clinical Trial Investigational Medicinal Product (CTIMP)
* Pulmonary function test with metacholine or beta-2-sympatico mimetic in last 2 hours.
* Any lung biopsy in the past 48 hours
* Currently undergoing anti-cancer treatment for lung cancer
18 Years
ALL
No
Sponsors
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Papworth Hospital NHS Foundation Trust
OTHER_GOV
University Hospitals, Leicester
OTHER
University College, London
OTHER
Universitätsklinikum Leipzig
OTHER
University Hospital, Antwerp
OTHER
University Hospital, Ghent
OTHER
University of Bari
OTHER
University of Athens
OTHER
Glenfield Hospital
OTHER
Peterborough and Stamford Hospitals NHS Foundation Trust
OTHER
University Hospitals of North Midlands NHS Trust
OTHER
Manchester University NHS Foundation Trust
OTHER_GOV
University Hospital Southampton NHS Foundation Trust
OTHER
Buckinghamshire Healthcare NHS Trust
OTHER
Wirral University Teaching Hospital NHS Trust
OTHER
South Tyneside and Sunderland NHS Foundation Trust
OTHER
Liverpool University Hospitals NHS Foundation Trust
OTHER_GOV
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
OTHER
Barnet and Chase Farm Hospitals NHS Trust
OTHER
Liverpool Heart and Chest Hospital NHS Foundation Trust
OTHER
Owlstone Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Marc P van der Schee, MD, PhD
Role: STUDY_DIRECTOR
Owlstone Medical
Locations
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UZA University Hospital Antwerp
Antwerp, , Belgium
UZG University Hospital Gent
Ghent, , Belgium
University Hospital Leipzig
Leipzig, , Germany
University Hospital Bari
Bari, , Italy
PapworthHospital
Cambridge, Cambridgeshire, United Kingdom
Wycombe
Buckingham, , United Kingdom
University Hospital of Leicester
Leicester, , United Kingdom
University Hospital Aintree NHS Foundation Trust
Liverpool, , United Kingdom
University College London
London, , 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
Peterborough and Stamford Hospital
Peterborough, , United Kingdom
South Tyneside District Hospital
South Shields, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Royal Stoke University Hospital NHS Trust
Stoke, , United Kingdom
Wirral University Teaching Hospital NHS Foundation Trust
Upton, , United Kingdom
Countries
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Related Links
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LuCID study homepage
Other Identifiers
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LuCID-2
Identifier Type: -
Identifier Source: org_study_id
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