Using cough samples to analyze lung health
Official title: Genetics of Lung Disease (Exhaled Breath DNA Methylation in Lung Carcinogenesis)
Run by Albert Einstein College of Medicine · NCT05854563 · Data updated 2026-11-12
This study is testing whether cough samples can help us find signs of lung diseases by comparing them to samples taken from healthy people and smokers.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | Albert Einstein College of Medicine Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Status | Recruiting |
| Started | March 28, 2023 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | January 13, 2026 |
| Trial ID | NCT05854563 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 21 and older who are undergoing bronchoscopy for diagnostic purposes.
✕Probably not a fit
Patients with conditions that prevent comfortable cough collection or those with contraindications to bronchoscopy 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 observational study aims to explore cough as a non-invasive method for capturing large molecules like DNA and proteins from the lungs. The researchers will collect cough specimens from healthy volunteers and current smokers, comparing them to samples obtained through bronchoscopy and mouthrinse. The study will focus on analyzing these cough samples for somatic mutations and lung-specific proteins, with the goal of developing a platform for early detection and risk assessment of lung diseases. The methodology includes advanced sequencing techniques and proteomic analysis to validate the efficacy of cough as a diagnostic tool.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate detection of lung diseases, improving patient outcomes.
How similar studies have gone: While the use of cough samples for lung diagnostics is relatively novel, similar studies exploring non-invasive methods for lung disease detection have shown promise.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: minimum age of 21 years * Gender: Male and Female adults * Ethnicity: All ethnic groups and races * Subjects undergoing bronchoscopy for diagnostic purposes or therapy * Subjects without a known diagnosis of lung cancer who are not scheduled for lung tissue collection procedures * Subjects with a known or suspected diagnosis of asthma or COPD and are scheduled for a visit at Montefiore Asthma or COPD Center and individual practices, and/or in-hospital with exacerbation Exclusion Criteria: * Bleeding diathesis or known coagulopathy precluding clinically indicated biopsy (e.g., INR\>1.3, PTTr\>1.3), thrombocytopenia \<50,000, uremia with serum creatinine \>3.0 * Unstable angina * Recent myocardial infarction (within 3 months), * Uncontrolled congestive heart failure or severe pulmonary hypertension (mean PAP\>75 mmHg)
Where it's running
-
Albert Einstein College of Medicine
The Bronx, New York, United States Recruiting
Study contacts
- Principal investigator: Simon D Spivack, MD — Albert Einstein College of Medicine
- Study coordinator: Aham Okorozo, MD
- Email: ahamefule.okorozo@einsteinmed.edu
- Phone: 718-678-1035
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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.