Biomarkers in the Nose, Throat, and Lung Tissue of Smokers and Non-Smokers

OBJECTIVES:

Primary

- Define the molecular and biochemical profiles of airway epithelium of smokers with no
disease, smokers with airflow obstruction and abnormal sputum cytology, and non-smokers.

Secondary

- Assess the occurrence of abnormalities in non-smokers, smokers with no disease, smokers
with various grades of dysplasia, and smokers with lung cancer.

OUTLINE: Patients are stratified according to smoking status (smoker vs non-smoker) and
disease (no disease vs airflow obstruction and abnormal sputum cytology vs various grades of
dysplasia vs lung cancer).

Biological samples are collected and analyzed for future research studies.

PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study.

Inclusion Criteria:

1. - Adults > 45 years of age, to be age matched with a previously enrolled cohort of
current and ex-smokers with airflow obstruction and moderate atypia on sputum
cytology, to be included in the following groups.

2. - Non-smoking (less than 100 cigarettes per lifetime) controls >50 years of age, to be
age matched with a previously enrolled cohort with airflow obstruction (FEV1 < 75%
predicted and FEV1/FVC < 75%) and moderate atypia on sputum cytology.

3. - Current smokers with > 30 pack years, no airflow obstruction (FEV1 > 90% predicted)
or lung cancer, >50 years of age, to be age matched with a previously enrolled cohort
with airflow obstruction and moderate atypia on sputum cytology .

4. - No prior history of a head and neck or bronchogenic carcinoma.

5. - Patients must be fully informed of the investigational nature of this study and must
sign an informed consent in accordance with institutional and FDA guidelines.

Exclusion Criteria:

1. - Clinically apparent bleeding diathesis.

2. - Cardiac dysrhythmia that is potentially life-threatening, such as ventricular
tachycardia, multifocal premature ventricular contractions or supraventricular
tachycardias with a rapid ventricular response. Well-controlled atrial fibrillation or
rare (< 2/minute) premature ventricular contractions are not exclusionary.

3. - Hypoxemia (less than 90% saturation with supplemental oxygen) during bronchoscopy.

4. - Evidence of clinically active coronary artery disease, including myocardial
infarction within 6 weeks, chest pain, or poorly controlled congestive heart failure,
or any other serious medical condition which would preclude a patient from undergoing
a bronchoscopy.

5. - Acute bronchitis or pneumonia within 8 weeks.

6. - Inability to give informed consent.

7. - Current smokers with no airflow obstruction may not have a history of coughing more
than two times /week.