Nashville Early Diagnosis Lung Cancer Project

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.

Conditions

• Lung Cancer

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Vanderbilt-Ingram Cancer Center

  lead OTHER

Principal Investigators

• Eric Grogan, MD · Vanderbilt-Ingram Cancer Center

Eligibility

Min Age

55 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-04-30

Primary Completion

2026-10-31

Completion

2026-11-30

Countries

• United States

Study Locations