Evaluating lung cancer biomarkers in breath for high-risk individuals
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.
Run by The Institute of Molecular and Translational Medicine, Czech Republic · NCT06016569 · Data updated 2026-11-12
This study is testing if new lung cancer markers found in breath can help identify the disease in older smokers better than traditional scans.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 55 Years to 74 Years |
| Sex | All |
| Enrollment | 3200 (estimated) |
| Sponsor | The Institute of Molecular and Translational Medicine, Czech Republic Academic / other |
| Locations | 3 sites (Brno and 2 other locations) |
| Status | Recruiting |
| Started | June 1, 2023 |
| Main results expected | December 31, 2029 |
| Study ends | December 2030 |
| Registry record updated | February 12, 2026 |
| Trial ID | NCT06016569 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 55-74 who are current or former smokers with a history of at least 20 pack-years of smoking.
✕Probably not a fit
Patients with a previous diagnosis of lung cancer or those with advanced dementia or acute exacerbations of chronic obstructive pulmonary disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial aims to assess the effectiveness of newly identified lung cancer biomarkers found in exhaled breath condensate as a diagnostic tool, comparing it to low-dose computed tomography (LDCT) screening. Participants aged 55-74 with a significant smoking history will be stratified into risk groups based on these biomarkers and other clinical data. The study seeks to improve early lung cancer diagnosis and reduce unnecessary interventions by validating the biomarkers' ability to differentiate between malignant and benign lung nodules. The ultimate goal is to lower lung cancer mortality rates in high-risk populations through enhanced screening methods.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of lung cancer, potentially reducing mortality rates in high-risk patients.
How similar studies have gone: Other studies have shown promise in using breath analysis for cancer detection, but this specific approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Masaryk Memorial Cancer Institute
Brno, Czechia Recruiting -
University Hospital
Olomouc, Czechia Not yet recruiting -
General University Hospital in Prague
Prague, Czechia Not yet recruiting
Study contacts
- Study coordinator: Marian Hajduch, MD, PhD.
- Email: marian.hajduch@upol.cz
- Phone: +420 585632083
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.