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

Analysis of Intermediate Endpoint Biomarkers in the Respiratory Epithelium of Smokers Compared to Non-Smoking Controls

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Precancerous Condition

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 Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center at UC Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

High risk for lung cancer and age matched normal volunters

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Molecular and biochemical profiles	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.	Upon completion of trial

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of abnormalities	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.	Upon completion of trial

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: York E. Miller, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: May 1, 2000
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: May 9, 2009
• First Submitted That Met QC Criteria: May 9, 2009
• First Posted (Estimate): May 12, 2009

Study Record Updates

• Last Update Posted (Actual): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 13, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: non-small cell lung cancer; small cell lung cancer; squamous lung dysplasia
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Precancerous Conditions
• Other Study ID Numbers: 95-413; P50CA058187 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No