Biomarkers in the Nose, Throat, and Lung Tissue of Smokers and Non-Smokers (NCT00897364) | Clinical Trial Compass
CompletedNot Applicable
Biomarkers in the Nose, Throat, and Lung Tissue of Smokers and Non-Smokers
United States112 participantsStarted 2000-05
Plain-language summary
RATIONALE: Studying samples of tissue from smokers and non-smokers in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This phase II study is looking at biomarkers in the nose, throat, and lung tissue of smokers and non-smokers.
Who can participate
Age range45 Years
SexALL
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Inclusion criteria
ā. \- 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.
ā. \- 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.
ā. \- 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 .
ā. \- No prior history of a head and neck or bronchogenic carcinoma.
ā. \- 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
ā. \- Clinically apparent bleeding diathesis.
ā. \- 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.
ā. \- Hypoxemia (less than 90% saturation with supplemental oxygen) during bronchoscopy.
ā. \- 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.