Nashville Early Diagnosis Lung Cancer Project
Conditions
Lung Cancer
Conditions: official terms
Lung Neoplasms
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: Sputum sample Type: Procedure
Name: Pulmonary function tests Type: Procedure
Name: Computerized tomography (CT) scan of the chest Type: Radiation
Name: Buccal epithelium collection Type: Other
Name: Nasal brushings Type: Procedure
Name: Bronchoscopy Type: Procedure
Name: Bronchoalveolar lavage Type: Procedure
Name: Blood sample collection Type: Procedure
Name: Urine sample Type: Procedure
Name: Questionnaire-data collection Type: Procedure
Overall Status
Recruiting
Summary
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 79 Years
Minimum Age: 50 Years
Gender: Both
Criteria: 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
Locations
Meharry Medical Center
Nashville, Tennessee, United States
Status: Recruiting
Contact: Clinical Trials Reporting Program - 800-811-8480
Vanderbilt University, Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Status: Recruiting
Contact: Clinical Trials Information Program - 800-811-8480
Veterans Administration
Nashville, Tennessee, United States
Status: Recruiting
Contact: Sanja Antic - 615-875-6099
Start Date
April 2011
Completion Date
November 2016
Sponsors
Vanderbilt-Ingram Cancer Center
Source
Vanderbilt-Ingram Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page