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

Completed

Conditions studied: Lung Cancer, Precancerous Condition

In brief

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.

Key facts

Study ID

NCT00897364

Run by

University of Colorado, Denver

People needed

112

Starts

2000-05-01

Expected to finish

2009-12-01

Last updated by the study team

2020-05-15

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• - Clinically apparent bleeding diathesis.
• - 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.
• - Hypoxemia (less than 90% saturation with supplemental oxygen) during bronchoscopy.
• - 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.
• - Acute bronchitis or pneumonia within 8 weeks.
• - Inability to give informed consent.
• - Current smokers with no airflow obstruction may not have a history of coughing more than two times /week.

Where it is running

• University of Colorado Cancer Center at UC Health Sciences Center — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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