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

Completed

• Conditions: Lung Cancer; Precancerous Condition

• Registration Number: NCT00897364
• Lead Sponsor: University of Colorado, Denver

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 looking at biomarkers in the nose, throat, and lung tissue of smokers and non-smokers.

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.

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.

Study Timeline

• Study Start: 2000-05
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2009-12-01
• Study Completion: 2009-12-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-13
• Last Update Posted: 2020-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Molecular and biochemical profiles	Upon completion of trial	Evaluation of both Molecular and Biochemical profiles of normal non-smokers, smokers with no apparent disease (no airflow obstruction or cancer), and smokers with airflow obstruction and abnormal sputum cytology.

Secondary Outcome Measures

Name	Time	Method
Occurrence of abnormalities	Upon completion of trial	Stratify abnormalities as to whether they occur frequently in normal non-smokers, smokers without disease, smokers with various grades of dysplasia, or smokers with lung cancer.

Trial Locations

Locations (1)

University of Colorado Cancer Center at UC Health Sciences Center; 🇺🇸 Aurora, Colorado, United States