The trial will evaluate if the newly identified biomarkers of lung cancer in exhaled breath condensate are as a diagnostic tool comparable to the low-dose computer tomography (LDCT) implemented in lung cancer screening recently. Due to the possibility to collect breath condensate at any medical workplace and due to the relatively low financial cost of examination of the collected breath condensate could improve early diagnosis of lung cancer, differential diagnostics of lung nodules and thereby reduce both the unnecessary interventions and deaths from this type of cancer.
Consent to participate in a clinical trial.
A clients within an age of 55-74 years.
priority will be given to clients who have smoked at least 30 pack-years.
preference will be given to a former smoker who has not smoked for less than 15 years.
Previous diagnosis of lung cancer.
Progressing malignant tumor on symptomatic treatment.
Advanced dementia
Chronic obstructive pulmonary disease or other inflammatory disease in the phase of acute exacerbation.
Single group
Exhaled breath condensate sampling
Diagnostic testPatient will breath for approx. 10 minutes to a breath condenser. The exhaled breath sample will be condensed and freezed.
Blood sampling
Diagnostic testA venous blood sample will be taken for further biomarker analysis.
LDCT
Procedure/SurgeryLDCT scan will be performed.
Vital signs
Diagnostic testBlood pressure, weight, height, pulse, oxygen saturation will be measured.
Spirometry
Diagnostic testSpirometry will be performed.
Validation of the multiplex protein signature in exhaled air
Validation of the multiplex protein signature in exhaled breath condensate based on the comparison with the LDCT.
Validation of the multiplex protein signature in exhaled breath for differential diagnostics of lung nodules
Validation of the multiplex protein signature in exhaled breath for differential diagnostics of lung nodules
Assessment of the effectiveness of the screening program
Assesment of the effectiveness of the screening procedure to reduce lung cancer mortality and overall mortality in the group with FEV1 (forced expiratory volume at 1 second) pre-bronchodilation 60-75% compared with the entire group of examinees.
Total time of diagnosis of the nodule
The total time of diagnosis of a solitary pulmonary nodule in positively screened patients for whom only observation is not a sufficient procedure.
Comparison of costs of screening procedures
Comparison of the costs of the screening procedures for exhaled breath condensate sample and LDCT procedure. This will be asssessed based on the individula patient data: total screening costs per patient from Healthcare registry in Czech Republic.
Assessment of success of the anti-smoking intervention
Percentage success of the anti-smoking intervention in the examined probands.
Number of newly captured interstitial lung processes
The number of newly captured interstitial lung processes will also be evaluated.
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The Institute of Molecular and Translational Medicine, Czech Republic
Lead sponsor
Cancer Research Foundation CR
Collaborator
