Clinical trial NCT00897364: Biomarkers in the Nose, Throat, and Lung Tissue of Smokers and Non-Smokers
Official title: Analysis of Intermediate Endpoint Biomarkers in the Respiratory Epithelium of Smokers Compared to Non-Smoking Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Precancerous Condition
Keywords: non-small cell lung cancer
small cell lung cancer
squamous lung dysplasia
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 112
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: High risk for lung cancer and age matched normal volunters

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Molecular and biochemical profiles
timeFrame: Upon completion of trial
Secondary outcomes:
measure: Occurrence of abnormalities
timeFrame: Upon completion of trial
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Cancer Center at UC Health Sciences Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: York E. Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: