Lung CancerLuCIDNCT02612532
Lung Cancer Indicator Detection
A study testing ReCIVA breath sampler in people with Lung Cancer, run by Owlstone Ltd at 17 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- ReCIVA breath sampler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,603 participants
- Where
- 17 sitesin 4 countries
- Study dates
- 7 Oct 2015to 22 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- (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
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
United Kingdom13 sites
Wycombe
Buckingham
PapworthHospital
Cambridge, Cambridgeshire
University Hospital of Leicester
Leicester
University Hospital Aintree NHS Foundation Trust
Liverpool
University College London
London
Watford Hospital NHS Trust
London
University Hospital of South Manchester NHs Foundation Trust
Manchester
Nottingham University Hospital NHS Trust
Nottingham
Peterborough and Stamford Hospital
Peterborough
South Tyneside District Hospital
South Shields
Southampton General Hospital
Southampton
Royal Stoke University Hospital NHS Trust
Stoke
Wirral University Teaching Hospital NHS Foundation Trust
Upton
Belgium2 sites
UZA University Hospital Antwerp
Antwerp
UZG University Hospital Gent
Ghent
About this study
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- ReCIVA breath sampler
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReCIVA breath samplerDevice
Device developed for standardised collection of breath samples http://www.owlstonenanotech.com/medical/products/reciva
| Study group | Role | What they receive |
|---|---|---|
| LuCID | Experimental | 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) Receives: Device: ReCIVA breath sampler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve for the diagnostic algorithm for lung cancer with optimal point sensitivity, specificity negative and positive predictive values.
Diagnostic accuracy of VOC analysis for Lung Cancer diagnosis based on pattern recognition analysis of raw VOC-spectra generated by Lonestar analysis of breath.
Measured: 2 years
Secondary outcomes (2)
Fraction of within group variability in exhaled VOCs explained by factors not primarily related to disease proces
Assessment of potential parameters affecting exhaled VOCs other than lung cancer such as smoking, diet and co-morbidities
Measured: 2 years
Identified exhaled biomarkers associated with tumor stage and size.
Analysis of correlation between exhaled biomarkers and the type, stage and size of the pulmonary tumor.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study start7 Oct 2015
- Primary completionMar 2021
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,603 participants (actual)
Sponsor and investigators
- Lead sponsor
- Owlstone Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Papworth Hospital NHS Foundation Trust, 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
- Responsible party
- Sponsor
- Investigators
- Marc P van der Schee, MD, PhD, Study director, Owlstone Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612532
- Sponsor's protocol ID
- LuCID-2
- Acronym
- LuCID
- Status last verified
- Jun 2023
- First submitted
- 18 Nov 2015
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer Indicator Detection
- ClinicalTrials.gov ID
- NCT02612532
- Acronym / sponsor ID
- LuCID / LuCID-2
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,603 participants (actual)
- Lead sponsor
- Owlstone LtdIndustry (pharma, biotech, devices)
- Collaborators
- Papworth Hospital NHS Foundation Trust, 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
- Study start
- 7 Oct 2015 (actual)
- Primary completion
- Mar 2021 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LuCID | Experimental | Device: ReCIVA breath samplerStandardised 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (5 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReCIVA breath samplerDevice developed for standardised collection of breath samples http://www.owlstonenanotech.com/medical/products/reciva | Device | LuCID |
Primary outcome
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 secondary outcomes
Fraction of within group variability in exhaled VOCs explained by factors not primarily related to disease proces
Time frame: 2 years
Identified exhaled biomarkers associated with tumor stage and size.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- LuCID study homepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc P van der Schee, MD, PhD study director
Owlstone Medical
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReCIVA breath sampler in people with Lung Cancer, run by Owlstone Ltd at 17 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United Kingdom, Belgium, Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.