Purpose

This screening study will address the lack of molecular strategies for the early detection of lung cancer and integrate those with epidemiological and imaging strategies. The hypothesis is that the repeated measure of biomarkers of risk obtained from the molecular analysis of biological specimens including those from bronchoscopy (bronchial brushings and biopsies) may contribute to the refinement of high-risk populations and allow an earlier clinical diagnosis. The goal of the investigators study is to provide screening for lung cancer in a high-risk population. In this prospective cohort it will be tested whether repeated measure of biomarkers of risk allows early detection of lung cancer.

Condition

Eligibility

Eligible Ages
Between 50 Years and 79 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 50 - 79 years of age, Current smoker with at least 25 years of smoking, at least 10 cigarettes/day, or former smoker at least 20 PKY history of cigarette smoking total, who quit 20 years ago or less
  • 6 year risk of ≥2.5% using Tammemagi Lung Cancer Risk Prediction Calculator: www.brocku.ca/cancerpredictionresearch

Exclusion Criteria

  • History of diagnosis/treatment of lung cancer in the past 2 years or of head/neck or esophageal cancer in the last 1 year.
  • Inability to provide informed consent

Study Design

Phase
N/A
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Screening These high-risk subjects will undergo screening for lung cancer. All subjects will undergo all listed interventions
  • Procedure: Sputum sample
    This is a collection of sputum (mucous) you cough up. Three morning samples will be collected at one time. Sputum will be collected at baseline, year 1, year 2 and year 5.
  • Procedure: Pulmonary function tests
    A series of different breathing tests designed to measure lung function and to determine the presence or absence of chronic obstructive pulmonary disease will be performed at baseline.
  • Radiation: Computerized tomography (CT) scan of the chest
    A CT scan uses x-rays to take detailed pictures of the chest. Performed at baseline, year 2 and year 5. If nodules are present, CT scans will be performed every 3 months for the first year of the study.
  • Other: Buccal epithelium collection
    Collect cells from the inside of the cheek. Samples will be collected at baseline and yearly to year 5.
  • Procedure: Nasal brushings
    A cytobrush is used to remove cells on the surface of the inside of the nose. Samples will be collected at baseline and yearly to year 5.
  • Procedure: Bronchoscopy
    A flexible tube with a light and a camera will be inserted through the nose or mouth, and into the lungs to look at the airway. Bronchial tissue will be obtained.
  • Procedure: Bronchoalveolar lavage
    During a bronchoscopy, a flexible tube with a light and a camera is passed through the mouth or nose into the lungs and fluid is squirted into a small part of the lung and collected for examination. Bronchoscopies will be performed at baseline and at year 5.
  • Procedure: Blood sample collection
    A venous blood sample will be collected for testing of biomarkers and other relevant tests. Blood will be taken at baseline and yearly to year 5.
  • Procedure: Urine sample
    Urine will be collected for routine urine tests at baseline and yearly to year 5.
  • Procedure: Questionnaire-data collection
    A questionnaire about the patient's health, medical, and smoking history. Administered at baseline and yearly to year 5. Data will be taken from patient interviews and from the medical record.

Recruiting Locations

Vanderbilt University, Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37232
Contact:
Clinical Trials Information Program
800-811-8480

Veterans Administration
Nashville, Tennessee 37212
Contact:
Sanja Antic
615-875-6099

Meharry Medical Center
Nashville, Tennessee 37232
Contact:
Clinical Trials Reporting Program
800-811-8480

More Details

NCT ID
NCT01475500
Status
Recruiting
Sponsor
Vanderbilt-Ingram Cancer Center

Study Contact

VICC Clinical Trials Information Program
800-811-8480

Detailed Description

It is proposed to test the hypotheses in a screening study of high risk individuals (characterized by an established prediction rule). The expected prevalence of lung cancer in this high risk group is estimated to be 2% per year. All individuals benefit from clinic visit, low-dose Chest CT, spirometry and auto-fluorescence bronchoscopy at baseline, Chest CT, follow-up doctor visit, and auto-fluorescence bronchoscopy at least at year 2 and 5.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.