NCT01475500

Nashville Early Diagnosis Lung Cancer Project

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 480 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-04-01
• Primary completion: 2026-10-31
• Completion: 2026-11-30
• First posted: 2011-11-21
• Last updated: 2023-12-12

Locations

2 sites across 1 country: United States