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

Lung Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06016569
• Other study ID #: 60096
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 2030

Study information

• Verified date: August 2023
• Source: The Institute of Molecular and Translational Medicine, Czech Republic
• Contact: Marian Hajduch, MD, PhD.
• Phone: +420585632083
• Email: marian.hajduch[@]upol.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3200
• Est. completion date: December 2030
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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.
• 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.
• Spirometry
Spirometry will be performed.

Locations

Country	Name	City	State
Czechia	Masaryk Memorial Cancer Institute	Brno
Czechia	University Hospital	Olomouc
Czechia	General University Hospital in Prague	Praha

Sponsors (2)

Lead Sponsor	Collaborator
The Institute of Molecular and Translational Medicine, Czech Republic	Cancer Research Foundation CR

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of newly captured interstitial lung processes	The number of newly captured interstitial lung processes will also be evaluated.	5 years
Primary	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.	5 years
Primary	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	5 years
Primary	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.	5 years
Secondary	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.	5 years
Secondary	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.	5 years
Secondary	Assessment of success of the anti-smoking intervention	Percentage success of the anti-smoking intervention in the examined probands.	5 years