Using cough samples to analyze lung health
Genetics of Lung Disease (Exhaled Breath DNA Methylation in Lung Carcinogenesis)
Albert Einstein College of Medicine · NCT05854563
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 |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Albert Einstein College of Medicine (other) |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT05854563 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21 and older who are undergoing bronchoscopy for diagnostic purposes.
Not a fit: Patients with conditions that prevent comfortable cough collection or those with contraindications to bronchoscopy may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
The Bronx, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lung Diseases, Lung Cancer, Lung Diseases, Obstructive, Lung Diseases, Interstitial, Lung Inflammation