Nashville Early Diagnosis Lung Cancer Project

Vanderbilt University Medical Center

Status

Active, not recruiting

Conditions

Lung Cancer

Treatments

Other: Buccal epithelium collection

Procedure: Questionnaire-data collection

Procedure: Bronchoscopy

Procedure: Nasal brushings

Procedure: Urine sample

Procedure: Sputum sample

Radiation: Computerized tomography (CT) scan of the chest

Procedure: Pulmonary function tests

Procedure: Blood sample collection

Procedure: Bronchoalveolar lavage

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT01475500

VICC THO 1078

U01CA152662 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

480 patients

Sex

All

Ages

55 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

55 - 80 years of age
Current smoker or former smoker. If former smoker, must have quit smoking less than 15 years ago
>/= 30 pack year of smoking history

Exclusion criteria

History of diagnosis/treatment of lung cancer in the past 2 years
History of head/neck or esophageal cancer in the last 1 year
Inability to provide informed consent
Participants in whom stopping anti-platelet or anti-coagulation therapy would have an adverse effect (DVT, mechanical heart valves, unstable coronary syndrome, etc.)