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Lung Cancer Indicator Detection (LuCID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02612532
Recruitment Status : Recruiting
First Posted : November 24, 2015
Last Update Posted : June 1, 2017
Sponsor:
Collaborators:
Papworth Hospital
University Hospitals, Leicester
University College, London
Universitätsklinikum Leipzig
University Hospital, Antwerp
University Hospital, Ghent
University of Bari
University of Athens
Glenfield Hospital
Peterborough and Stamford Hospitals NHS Foundation Trust
University Hospitals of North Midlands NHS Trust
Manchester University NHS Foundation Trust
University Hospital Southampton NHS Foundation Trust
Buckinghamshire Healthcare NHS Trust
Wirral University Teaching Hospital NHS Trust
South Tyneside and Sunderland NHS Foundation Trust
Liverpool University Hospitals NHS Foundation Trust
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Barnet and Chase Farm Hospitals NHS Trust
Liverpool Heart and Chest Hospital NHS Foundation Trust
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lung Cancer Device: ReCIVA breath sampler Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Lung Cancer Indicator Detection
Study Start Date : October 2015
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)
Device: ReCIVA breath sampler
Device developed for standardised collection of breath samples http://www.owlstonenanotech.com/medical/products/reciva




Primary Outcome Measures :
  1. Area Under the Curve for the diagnostic algorithm for lung cancer with optimal point sensitivity, specificity negative and positive predictive values. [ Time Frame: 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 :
  1. Fraction of within group variability in exhaled VOCs explained by factors not primarily related to disease proces [ Time Frame: 2 years ]
    Assessment of potential parameters affecting exhaled VOCs other than lung cancer such as smoking, diet and co-morbidities

  2. Identified exhaled biomarkers associated with tumor stage and size. [ Time Frame: 2 years ]
    Analysis of correlation between exhaled biomarkers and the type, stage and size of the pulmonary tumor.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Recruitment for these patients will be done from NHS hospitals whom identify or follow-up on patients suspected of having lung cancer.

  • Inclusion criteria:

    • Older than 18 years at time of consent
    • 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:

    • (Anticipated) inability to complete breath sampling procedure due to e.g. hyper- or hypo-ventilation, respiratory failure or claustrophobia when wearing the sampling mask
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612532


Contacts
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Contact: Marc P van der Schee, MD, PhD +01223 428200 marc.vanderschee@owlstone.co.uk
Contact: Paul Boyle +01223 428200 billy.boyle@owlstone.co.uk

Locations
Show Show 17 study locations
Sponsors and Collaborators
Owlstone Ltd
Papworth Hospital
University Hospitals, Leicester
University College, London
Universitätsklinikum Leipzig
University Hospital, Antwerp
University Hospital, Ghent
University of Bari
University of Athens
Glenfield Hospital
Peterborough and Stamford Hospitals NHS Foundation Trust
University Hospitals of North Midlands NHS Trust
Manchester University NHS Foundation Trust
University Hospital Southampton NHS Foundation Trust
Buckinghamshire Healthcare NHS Trust
Wirral University Teaching Hospital NHS Trust
South Tyneside and Sunderland NHS Foundation Trust
Liverpool University Hospitals NHS Foundation Trust
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Barnet and Chase Farm Hospitals NHS Trust
Liverpool Heart and Chest Hospital NHS Foundation Trust
Investigators
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Study Director: Marc P van der Schee, MD, PhD Owlstone Medical
Additional Information:
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Responsible Party: Owlstone Ltd
ClinicalTrials.gov Identifier: NCT02612532    
Other Study ID Numbers: LuCID-2
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases