Exhaled breath condensate sampling: Patient will breath for approx. 10 minutes to a breath condenser. The exhaled breath sample will be condensed and freezed.
Blood sampling: A venous blood sample will be taken for further biomarker analysis.
LDCT: LDCT scan will be performed.
Vital signs: Blood pressure, weight, height, pulse, oxygen saturation will be measured.
Spirometry: Spirometry will be performed.
Study summary
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.
Eligibility
Sex
ALL
Min age
55 Years
Max age
74 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Consent to participate in a clinical trial.
2. A clients within an age of 55-74 years.
3. Current smoker or ex-smoker who has smoked at least 20 pack-years, provided that:
1. priority will be given to clients who have smoked at least 30 pack-years.
2. preference will be given to a former smoker who has not smoked for less than 15 years.
Exclusion Criteria:
1. Previous diagnosis of lung cancer.
2. Progressing malignant tumor on symptomatic treatment.
3. Advanced dementia
4. Chronic obstructive pulmonary disease or other inflammatory disease in the phase of acute exacerbation.
Primary outcome measure(s)
Validation of the multiplex protein signature in exhaled air — 5 years 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 — 5 years Validation of the multiplex protein signature in exhaled breath for differential diagnostics of lung nodules
Assessment of the effectiveness of the screening program — 5 years 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.
Trial sites (3)
Facility
City
Region
Status
Masaryk Memorial Cancer Institute
Brno
Czechia
Recruiting
University Hospital
Olomouc
Czechia
Not Yet Recruiting
General University Hospital in Prague
Prague
Czechia
Not Yet Recruiting
More The Institute of Molecular and Translational Medicine, Czech Republic trials in Czechia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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