Lung Cancer Indicator Detection (LuCID)

June 16, 2023 updated by: Owlstone Ltd
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2603

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium
        • UZA University Hospital Antwerp
      • Gent, Belgium
        • UZG University Hospital Gent
  • Germany
      • Leipzig, Germany, 04103
        • University Hospital Leipzig
  • Italy
      • Bari, Italy
        • University Hospital Bari
  • United Kingdom
      • Buckingham, United Kingdom
        • Wycombe
      • Leicester, United Kingdom
        • University Hospital of Leicester
      • Liverpool, United Kingdom
        • University Hospital Aintree NHS Foundation Trust
      • London, United Kingdom
        • University College London
      • London, United Kingdom
        • Watford Hospital NHS Trust
      • Manchester, United Kingdom
        • University Hospital of South Manchester NHS Foundation Trust
      • Nottingham, United Kingdom
        • Nottingham University Hospital NHS Trust
      • Peterborough, United Kingdom
        • Peterborough and Stamford Hospital
      • South Shields, United Kingdom
        • South Tyneside District Hospital
      • Southampton, United Kingdom
        • Southampton General Hospital
      • Stoke, United Kingdom
        • Royal Stoke University Hospital NHS Trust
      • Upton, United Kingdom
        • Wirral University Teaching Hospital NHS Foundation Trust
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom
        • PapworthHospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Owlstone Ltd

Collaborators

University College, London
University of Athens
University Hospital, Ghent
University Hospitals, Leicester
Liverpool University Hospitals NHS Foundation Trust
University Hospital, Antwerp
Manchester University NHS Foundation Trust
University Hospital Southampton NHS Foundation Trust
Liverpool Heart and Chest Hospital NHS Foundation Trust
Papworth Hospital NHS Foundation Trust
Buckinghamshire Healthcare NHS Trust
South Tyneside and Sunderland NHS Foundation Trust
University of Bari
Universitätsklinikum Leipzig
University Hospitals of North Midlands NHS Trust
Wirral University Teaching Hospital NHS Trust
Glenfield Hospital
Peterborough and Stamford Hospitals NHS Foundation Trust
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Barnet and Chase Farm Hospitals NHS Trust

Investigators

  • Study Director: Marc P van der Schee, MD, PhD, Owlstone Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2015

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

December 22, 2022

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimated)

November 24, 2015

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LuCID-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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