Nashville Early Diagnosis Lung Cancer Project
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
|
Outcome Measures
Primary Outcome Measures
- To compare candidate biomarkers over time among participants who did and did not develop lung cancer [at baseline and yearly to year 5]
Blood, sputum, urine, nasal washings, buccal epithelium, endobronchial tissue, and bronchioalveolar washings are examined for biomarkers present in patients who develop lung cancer compared with those patients who do not develop lung cancer. Baseline and yearly screening results will be compared in the two groups.
Secondary Outcome Measures
- To identify and validate new biomarkers that are associated with lung cancer risk factors and premalignant lesions. [at baseline and yearly to year 5]
Blood, sputum, urine, nasal washings, buccal epithelium, endobronchial tissue, and bronchioalveolar washings are examined for presently unknown biomarkers that occur in patients with lung cancer and in patients who do not have lung cancer but who may be at further increased risk of lung cancer.
- To assess changes in prevalence and grade of pre-invasive lesions in this cohort. [baseline, at years 2 and 5 (abnormal tissue will re-examined every 6 months)]
Endobronchial tissue will be examined under a microscope for presence of changes in the cells that are abnormal but which are not invasive cancer.
- To describe patients eligible for future chemoprevention clinical trials. [at year 5]
Inclusion criteria for those patients who, based on their biomarker profile, are at increased risk of invasive lung cancer and who may benefit from clinical trials that will study chemoprevention strategies for lung cancer.
Eligibility Criteria
Criteria
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.)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Veterans Administration | Nashville | Tennessee | United States | 37212 |
| 2 | Vanderbilt University, Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | United States | 37232 |
Sponsors and Collaborators
- Vanderbilt-Ingram Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Eric Grogan, MD, Vanderbilt-Ingram Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VICC THO 1078
- U01CA152662