Clinical trial NCT06016569: Study of Early Cancer Biomarkers in Breath Condensate in Population of Individuals with High-Risk of Lung Cancer Undergoing LDCT Screening.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Lung Cancer
Breath Condensate
Biomarker
Screening
Early Cancer Detection
Lead sponsor: The Institute of Molecular and Translational Medicine, Czech Republic
Sponsor class: OTHER
Collaborators: name: Cancer Research Foundation CR
First posted: 2023-08-29
Enrollment: 3200
Sex: ALL
Minimum age (years): 55
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility criteria: 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 outcomes:
measure: Validation of the multiplex protein signature in exhaled air
timeFrame: 5 years
measure: Validation of the multiplex protein signature in exhaled breath for differential diagnostics of lung nodules
timeFrame: 5 years
measure: Assessment of the effectiveness of the screening program
timeFrame: 5 years
Secondary outcomes:
measure: Total time of diagnosis of the nodule
timeFrame: 5 years
measure: Comparison of costs of screening procedures
timeFrame: 5 years
measure: Assessment of success of the anti-smoking intervention
timeFrame: 5 years
Other outcomes:
measure: Number of newly captured interstitial lung processes
timeFrame: 5 years
Locations:
city: Brno
country: Czechia
facility: Masaryk Memorial Cancer Institute
city: Olomouc
country: Czechia
facility: University Hospital
city: Praha
country: Czechia
facility: General University Hospital in Prague
Study officials:
affiliation: IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry
name: Marian Hajduch, MD, PhD.
role: STUDY_DIRECTOR
References: