NCT06016569

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,200 (estimated)
• Sponsor: The Institute of Molecular and Translational Medicine, Czech Republic · Academic / Other
• Sex: All
• Age: 55 Years – 74 Years
• Healthy volunteers: Accepted

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.

Detailed description

The project aims to validate newly identified biomarkers of lung cancer in breath condensate for the diagnosis and triage of lung nodules (malignant versus benign), further set the mechanisms of the functioning of the lung cancer screening center, validate the quality indicators of LDCT screening for the Czech Republic and stratify the cohort of individuals so that optimized output of screening activities. Patients aged 55-74 years with a heavy smoking load (more than 20, preferably more than 30 pack/years) will be divided into risk groups according to biomarkers in exhaled air, clinical/anamnesis data and the degree of obstructive ventilation disorder according to spirometry and subsequently there will be effective stratification of the risk of lung carcinoma. The group with the highest risk of developing lung cancer will then be diagnosed with early lung cancer using ultra-low-dose computed tomography of the chest. This will lead to early diagnosis and subsequently to a reduction in the mortality rate of the monitored active group compared to the historical cohort. The primary outcome will be the validation of the multiplex protein signature in exhaled air, 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% with the entire group of examinees. The secondary outcome will then be the total time of diagnosis of a solitary pulmonary nodule in positively screened patients for whom only observation is not a sufficient procedure. Another secondary outcome will be the costs of screening procedures for individual groups and the percentage of success of the anti-smoking intervention for the enrolled individuals. The number of newly captured interstitial lung processes will also be evaluated. Patients will be evaluated for 5 years at annual visits or earlier based on their LDCT result.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Exhaled breath condensate sampling	Patient will breath for approx. 10 minutes to a breath condenser. The exhaled breath sample will be condensed and freezed.
DIAGNOSTIC_TEST	Blood sampling	A venous blood sample will be taken for further biomarker analysis.
PROCEDURE	LDCT	LDCT scan will be performed.
DIAGNOSTIC_TEST	Vital signs	Blood pressure, weight, height, pulse, oxygen saturation will be measured.
DIAGNOSTIC_TEST	Spirometry	Spirometry will be performed.

Timeline

• Start date: 2023-06-01
• Primary completion: 2029-12-31
• Completion: 2030-12-01
• First posted: 2023-08-29
• Last updated: 2026-02-12

Locations

3 sites across 1 country: Czechia