Study of Early Cancer Biomarkers in Breath Condensate in Population of Individuals with High-Risk of Lung Cancer Undergoing LDCT Screening.

Not Applicable

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT06016569
• Lead Sponsor: The Institute of Molecular and Translational Medicine, Czech Republic

Brief 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.

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-08-22
• Study First Submitted QC: 2023-08-28
• Study First Posted: 2023-08-29
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-01
• Primary Completion: 2029-12-31
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.
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.
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

Secondary Outcome Measures

Name	Time	Method
Assessment of success of the anti-smoking intervention	5 years	Percentage success of the anti-smoking intervention in the examined probands.
Total time of diagnosis of the nodule	5 years	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	5 years	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.

Trial Locations

Locations (3)

Masaryk Memorial Cancer Institute; 🇨🇿 Brno, Czechia

University Hospital; 🇨🇿 Olomouc, Czechia

General University Hospital in Prague; 🇨🇿 Praha, Czechia