Vanderbilt Clinical Trials

Nashville Early Diagnosis Lung Cancer Project

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

Lung Cancer

Eligibility

Eligible Ages: Between 55 Years and 80 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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.)

Study Design

Phase
Study Type: Observational
Observational Model: Cohort
Time Perspective: Prospective

Arm Groups

Arm	Description	Assigned 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.

More Details

Status: Active, not recruiting
Sponsor: Vanderbilt-Ingram Cancer Center

Study Contact

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.