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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02612532|
Recruitment Status : Active, not recruiting
First Posted : November 24, 2015
Last Update Posted : February 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Device: ReCIVA breath sampler||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||520 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lung Cancer Indicator Detection|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2022|
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
- 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.
- 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
- 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.
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
|Study Director:||Marc P van der Schee, MD, PhD||Owlstone Medical|