Status:
COMPLETED
Biomarkers in the Nose, Throat, and Lung Tissue of Smokers and Non-Smokers
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Precancerous Condition
Eligibility:
All Genders
45+ years
Brief 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 looki...
Detailed Description
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. ...
Eligibility Criteria
Inclusion
- \- 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.
Exclusion
- \- 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.
Key Trial Info
Start Date :
May 1 2000
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00897364
Start Date
May 1 2000
End Date
December 1 2009
Last Update
May 15 2020
Active Locations (1)
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1
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045