Biomarker Discovery in Exhaled Breath Condensate (EBC) to discriminate pts with lung cancer CS I-IV from pts with COPD or lung fibrosis and healthy controls.
- Conditions
- C34.9Bronchus or lung, unspecified
- Registration Number
- DRKS00033788
- Lead Sponsor
- VOC-Advanced Breath Diagnostics GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 238
2.Cohort classification:
a. Cohort A: Smokers or nonsmokers with no signs or symptoms of lung cancer, COPD or lung fibrosis
b.Cohort B: Smokers or nonsmokers with known COPD or lung fibrosis but no symptoms or signs of lung cancer
c.Cohort C: Smokers or nonsmokers with yet untreated lung carcinoma CS I-IV with or without COPD or lung fibrosis
3. Able to sign informed consent form.
4. Able to understand study requirements and to provide EBC sample by tidal breathing into a EBC collection device
1. Suffering from major uncontrolled medical conditions that may interfere with study requirements such as fever, shortness of breath, cough/acute cold.
2. Previous malignancies
3. Patients with COPD GOLD IV or lung fibrosis with DLCO/TCLO < 30 %
4. Exacerbation of COPD within = 4 weeks before enrollment
5. Dry mouth and tongue with daily liquid intake of < 1 liter/day within last 48 hours
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Projected number EBC samples collected with sufficient quantity (= 80µl) for nano-LC-MS/MS analysis in at least or more than 90% of cases.<br>•Protein biomarker panel of predefined performance (Sensitivity > 90%, Specificity = 50% and NPV = 95%) to significantly discriminate cohorts A from B+C combined as well as A+B combined from C.<br>
- Secondary Outcome Measures
Name Time Method