Clinical trial · Interventional
Study of Early Cancer Biomarkers in Breath Condensate in Population of Individuals With High-Risk of Lung Cancer Undergoing LDCT Screening.
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sampling | Diagnostic Test | — | UNRESOLVED |
| Exhaled breath condensate sampling | Diagnostic Test | — | UNRESOLVED |
| LDCT | Procedure | — | UNRESOLVED |
| Spirometry | Diagnostic Test | — | UNRESOLVED |
| Vital signs | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LDCT and collection of breath condensate and blood sample
- description
- 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.
- interventionNames
- Diagnostic Test: Exhaled breath condensate sampling
- Diagnostic Test: Blood sampling
- Procedure: LDCT
- Diagnostic Test: Vital signs
- Diagnostic Test: Spirometry
Primary outcomes (3)
- measure
- Validation of the multiplex protein signature in exhaled air
- timeFrame
- 5 years
- description
- Validation of the multiplex protein signature in exhaled breath condensate based on the comparison with the LDCT.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available