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.

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. - Lung - EBC Biomarker Discovery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00033788

Enrollment

238

Registered

2024-03-04

Start date

2024-03-06

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C34.9

Interventions

Group 1: Cohort A: Smokers or nonsmokers with no signs or symptoms of lung cancer, COPD or lung fibrosis Cohort B: Smokers or nonsmokers with known COPD or lung fibrosis but no symptoms or signs of lu

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
•Projected number EBC samples collected with sufficient quantity (= 80µl) for nano-LC-MS/MS analysis in at least or more than 90% of cases. •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.	—

Countries

Germany

Contacts

Public ContactFelix Herth

Universitätsklinikum Heidelberg - Thoraxklinik

felix.herth@med.uni-heidelberg.de+49 6221 396 1200

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026