Lung CancerNCT06016569
Study of Early Cancer Biomarkers in Breath Condensate in Population of Individuals With High-Risk of Lung Cancer Undergoing LDCT Screening.
A study testing Exhaled breath condensate sampling, Blood sampling and LDCT in people with Lung Cancer, run by The Institute of Molecular and Translational Medicine, Czech Republic at 3 sites in Czechia.
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. Read more about this study
- Who is it for?
- Ages 55 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Exhaled breath condensate sampling, Blood sampling and LDCT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,200 participants
- Where
- 3 sitesCzechia
- Study dates
- 1 Jun 2023to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia3 sites, 3 recruiting
- Recruiting
Masaryk Memorial Cancer Institute
Brno, 65653
Pavel Turcani, MD, PhD., +420543136409, pavel.turcani@mou.cz
Martina Lojova, MSc., PhD., +420543136132, martina.lojova@mou.cz
- Not yet recruiting
University Hospital
Olomouc, 77900
Petr Jakubec, MD, PhD., +420588445918, petr.jakubec@fnol.cz
Miroslav Herman, prof.MD PhD., +420588443495, miroslav.herman@fnol.cz
- Not yet recruiting
General University Hospital in Prague
Prague, 12808
Jiri Votruba, MD, Ph.D., +420 224 969 355, jiri.votruba@vfn.cz
Lenka Navratova, MD, +420224969352, lenka.navratova@vfn.cz
About this study
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.
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.
Read the 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
- Being tested
- Exhaled breath condensate sampling, Blood sampling, LDCT, Vital signs, Spirometry
- Keywords
- Lung Cancer, Breath Condensate, Biomarker, Screening, Early Cancer Detection
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exhaled breath condensate samplingDiagnostic test
Patient will breath for approx. 10 minutes to a breath condenser. The exhaled breath sample will be condensed and freezed.
Blood samplingDiagnostic test
A venous blood sample will be taken for further biomarker analysis.
LDCTProcedure or surgery
Also called Low Dose Computer Tomography
LDCT scan will be performed.
Vital signsDiagnostic test
Blood pressure, weight, height, pulse, oxygen saturation will be measured.
SpirometryDiagnostic test
Spirometry will be performed.
| Study group | Role | What they receive |
|---|---|---|
| LDCT and collection of breath condensate and blood sample | Experimental | Each participant of the study will provide exhaled breath condensate sample and blood sample for further laboratory analyses. Each participant will have LDCT (low dose computer tomography) performed. A pulmonologist examines the patient for any concomitant diseases and performs spirometry. Vital signs will be measured. Receives: Diagnostic Test: Exhaled breath condensate sampling; Diagnostic Test: Blood sampling; Procedure: LDCT; Diagnostic Test: Vital signs; Diagnostic Test: Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
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
Measured: 5 years
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.
Measured: 5 years
Secondary outcomes (3)
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.
Measured: 5 years
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.
Measured: 5 years
Assessment of success of the anti-smoking intervention
Percentage success of the anti-smoking intervention in the examined probands.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Jun 2023
- Primary completion31 Dec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research Foundation CR
- Responsible party
- Sponsor
- Investigators
- Marian Hajduch, MD, PhD., Study director, IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016569
- Sponsor's protocol ID
- 60096
- Status last verified
- Jan 2026
- First submitted
- 22 Aug 2023
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06016569
- Acronym / sponsor ID
- 60096
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Breath Condensate, Biomarker, Screening, Early Cancer Detection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,200 participants (estimated)
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech RepublicUniversity, hospital or other
- Collaborators
- Cancer Research Foundation CR
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LDCT and collection of breath condensate and blood sample | Experimental | Diagnostic Test: Exhaled breath condensate sampling, Diagnostic Test: Blood sampling, Procedure: LDCT, Diagnostic Test: Vital signs, Diagnostic Test: SpirometryEach participant of the study will provide exhaled breath condensate sample and blood sample for further laboratory analyses. Each participant will have LDCT (low dose computer tomography) performed. A pulmonologist examines the patient for any concomitant diseases and performs spirometry. Vital signs will be measured. |
Who may qualify
- Ages
- 55 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exhaled breath condensate samplingPatient will breath for approx. 10 minutes to a breath condenser. The exhaled breath sample will be condensed and freezed. | Diagnostic test | LDCT and collection of breath condensate and blood sample |
| Blood samplingA venous blood sample will be taken for further biomarker analysis. | Diagnostic test | LDCT and collection of breath condensate and blood sample |
| LDCTAlso: Low Dose Computer TomographyLDCT scan will be performed. | Procedure or surgery | LDCT and collection of breath condensate and blood sample |
| Vital signsBlood pressure, weight, height, pulse, oxygen saturation will be measured. | Diagnostic test | LDCT and collection of breath condensate and blood sample |
| SpirometrySpirometry will be performed. | Diagnostic test | LDCT and collection of breath condensate and blood sample |
Primary outcome
Validation of the multiplex protein signature in exhaled air
Time frame: 5 years
Validation of the multiplex protein signature in exhaled breath condensate based on the comparison with the LDCT.
Validation of the multiplex protein signature in exhaled breath for differential diagnostics of lung nodules
Time frame: 5 years
Validation of the multiplex protein signature in exhaled breath for differential diagnostics of lung nodules
Assessment of the effectiveness of the screening program
Time frame: 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.
3 secondary outcomes
Total time of diagnosis of the nodule
Time frame: 5 years
Comparison of costs of screening procedures
Time frame: 5 years
Assessment of success of the anti-smoking intervention
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marian Hajduch, MD, PhD. study director
IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exhaled breath condensate sampling, Blood sampling and LDCT in people with Lung Cancer, run by The Institute of Molecular and Translational Medicine, Czech Republic at 3 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marian Hajduch, MD, PhD. (+420 585632083, marian.hajduch@upol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the multiplex protein signature in exhaled air (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.