Clinical trial NCT02612532: Lung Cancer Indicator Detection
Official title: Lung Cancer Indicator Detection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Owlstone Ltd
Sponsor class: INDUSTRY
Collaborators: name: Papworth Hospital NHS Foundation Trust
name: University Hospitals, Leicester
name: University College, London
name: Universitätsklinikum Leipzig
name: University Hospital, Antwerp
name: University Hospital, Ghent
name: University of Bari
name: University of Athens
name: Glenfield Hospital
name: Peterborough and Stamford Hospitals NHS Foundation Trust
name: University Hospitals of North Midlands NHS Trust
name: Manchester University NHS Foundation Trust
name: University Hospital Southampton NHS Foundation Trust
name: Buckinghamshire Healthcare NHS Trust
name: Wirral University Teaching Hospital NHS Trust
name: South Tyneside and Sunderland NHS Foundation Trust
name: Liverpool University Hospitals NHS Foundation Trust
name: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
name: Barnet and Chase Farm Hospitals NHS Trust
name: Liverpool Heart and Chest Hospital NHS Foundation Trust
First posted: 2015-11-24
Enrollment: 2603
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Area Under the Curve for the diagnostic algorithm for lung cancer with optimal point sensitivity, specificity negative and positive predictive values.
timeFrame: 2 years
Secondary outcomes:
measure: Fraction of within group variability in exhaled VOCs explained by factors not primarily related to disease proces
timeFrame: 2 years
measure: Identified exhaled biomarkers associated with tumor stage and size.
timeFrame: 2 years
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: UZA University Hospital Antwerp
city: Gent
country: Belgium
facility: UZG University Hospital Gent
city: Leipzig
country: Germany
facility: University Hospital Leipzig
city: Bari
country: Italy
facility: University Hospital Bari
city: Cambridge
country: United Kingdom
facility: PapworthHospital
state: Cambridgeshire
city: Buckingham
country: United Kingdom
facility: Wycombe
city: Leicester
country: United Kingdom
facility: University Hospital of Leicester
city: Liverpool
country: United Kingdom
facility: University Hospital Aintree NHS Foundation Trust
city: London
country: United Kingdom
facility: University College London
city: London
country: United Kingdom
facility: Watford Hospital NHS Trust
city: Manchester
country: United Kingdom
facility: University Hospital of South Manchester NHs Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital NHS Trust
city: Peterborough
country: United Kingdom
facility: Peterborough and Stamford Hospital
city: South Shields
country: United Kingdom
facility: South Tyneside District Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Stoke
country: United Kingdom
facility: Royal Stoke University Hospital NHS Trust
city: Upton
country: United Kingdom
facility: Wirral University Teaching Hospital NHS Foundation Trust
Study officials:
affiliation: Owlstone Medical
name: Marc P van der Schee, MD, PhD
role: STUDY_DIRECTOR
References: