Actively Recruiting

Age: 21Years +
All Genders
ID05854563

Genetics of Lung Disease Using Exhaled Breath DNA Methylation and Cough Capture for Lung Carcinogenesis

Led by Albert Einstein College of Medicine · Updated on 2026-01-13

2000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

A

Albert Einstein College of Medicine

Lead Sponsor

N

National Center for Advancing Translational Sciences (NCATS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating whether cough can serve as a non-invasive way to study the lungs for detecting large molecules like DNA and proteins. The study aims to develop and test a method that captures cough samples and isolates deep-lung specific extracellular vesicles (EVs), comparing these with invasive lung samples and mouth rinses from the same participants. This approach could help in early detection and risk assessment of lung diseases including lung cancer, asthma, and COPD. The study collects cough samples using a handheld chamber device, instructing participants to cough every 30 seconds for 10 minutes. The collected specimens, along with mouth rinse and bronchoalveolar lavage samples, are analyzed for DNA mutations using advanced sequencing and for lung-specific proteins through proteomic techniques. The research includes healthy volunteers, smokers, and people living with HIV, with comparisons made across these groups. Participants provide samples during clinical visits and are followed for up to 3 months to collect diagnostic updates. Researchers perform detailed DNA mutation and protein analyses on the samples to evaluate how well cough specimens represent deep lung material. The study emphasizes non-invasive collection and aims to support future development of large-scale clinical and public health applications for lung disease diagnosis and monitoring.

CONDITIONS

Brief Title

Cough Capture as a Portal Into the Lung

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 21 years or older
  • Male and female adults of all races and ethnic groups
  • Undergoing bronchoscopy for diagnostic or therapeutic reasons
  • No known diagnosis of lung cancer and not scheduled for lung tissue collection
  • Known or suspected diagnosis of asthma or COPD with scheduled visits at specialized centers or hospitalization for exacerbation
Not Eligible

You will not qualify if you...

  • Bleeding disorders preventing biopsy (e.g., INR > 1.3, low platelets < 50,000, high creatinine > 3.0)
  • Unstable angina
  • Recent heart attack within 3 months
  • Uncontrolled heart failure or severe pulmonary hypertension (mean pulmonary artery pressure > 75 mmHg)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Observational Sample Collection

Duration - Single day (up to 30 minutes for collection of all airway samples)

Participants provide samples including cough, mouthrinse, and bronchoalveolar lavage (BAL) during bronchoscopy as part of routine care to measure DNA mutation and proteomic profiles.

1 visit (in-person)

Medical Record Follow-up

Duration - 3 months

Participants are followed for 3 months through medical record review to gather updated diagnostics and clinical information.

No additional visits; data collection via medical record

Trial Site Locations

Total: 1 location

1

Albert Einstein College of Medicine

The Bronx, New York, United States, 10461

Actively Recruiting

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Research Team

A

Aham Okorozo, MD

K

Khulan Batbayar, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Exhaled breath condensate contains extracellular vesicles (EVs) that carry miRNA cargos of lung tissue origin that can be selectively purified and analyzed.

Megan I Mitchell, Iddo Z Ben-Dov, Kenny Ye...

https://pubmed.ncbi.nlm.nih.gov/38659349

Distinctive field effects of smoking and lung cancer case-control status on bronchial basal cell growth and signaling.

Olsida Zefi, Spencer Waldman, Ava Marsh...

https://pubmed.ncbi.nlm.nih.gov/39160511

Normal bronchial field basal cells show persistent methylome-wide impact of tobacco smoking, including in known cancer genes.

Batbayar Khulan, Kenny Ye, Miao Kevin Shi...

https://pubmed.ncbi.nlm.nih.gov/39980243