Study of Early Cancer Biomarkers in Breath Condensate in Population of Individuals With High-Risk of Lung Cancer Undergoing LDCT Screening.
Prospective Validation Study of Early Cancer Biomarkers in Breath Condensate of Individuals With High-Risk of Lung Cancer Undergoing Low-Dose Computer Tomography Based Screening.
The Institute of Molecular and Translational Medicine, Czech Republic
3,200 participants
Jun 1, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- Consent to participate in a clinical trial.
- A clients within an age of 55-74 years.
- Current smoker or ex-smoker who has smoked at least 20 pack-years, provided that:
- 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.
Exclusion Criteria4
- 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.
Interventions
Patient will breath for approx. 10 minutes to a breath condenser. The exhaled breath sample will be condensed and freezed.
A venous blood sample will be taken for further biomarker analysis.
LDCT scan will be performed.
Blood pressure, weight, height, pulse, oxygen saturation will be measured.
Spirometry will be performed.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06016569