Nashville Early Diagnosis Lung Cancer Project
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|ClinicalTrials.gov Identifier: NCT01475500|
Recruitment Status : Recruiting
First Posted : November 21, 2011
Last Update Posted : June 18, 2021
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|
|Lung Cancer||Procedure: Sputum sample Procedure: Pulmonary function tests Radiation: Computerized tomography (CT) scan of the chest Other: Buccal epithelium collection Procedure: Nasal brushings Procedure: Bronchoscopy Procedure: Bronchoalveolar lavage Procedure: Blood sample collection Procedure: Urine sample Procedure: Questionnaire-data collection|
|Study Type :||Observational|
|Estimated Enrollment :||410 participants|
|Official Title:||Nashville Early Diagnosis Lung Cancer Project|
|Actual Study Start Date :||April 2011|
|Estimated Primary Completion Date :||July 30, 2022|
|Estimated Study Completion Date :||November 30, 2022|
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.
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.
- To compare candidate biomarkers over time among participants who did and did not develop lung cancer [ Time Frame: 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.
- To identify and validate new biomarkers that are associated with lung cancer risk factors and premalignant lesions. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01475500
|Contact: Vanderbilt-Ingram Service for Timely Access||800-811-8480|
|Contact: Anel Muterspaugh||615-936-4244|
|United States, Tennessee|
|Veterans Administration||Active, not recruiting|
|Nashville, Tennessee, United States, 37212|
|Vanderbilt University, Vanderbilt-Ingram Cancer Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Vanderbilt-Ingram Service for Timely Access 800-811-8480|
|Contact: Anel Muterspaugh 615-936-4244|
|Principal Investigator: Eric Grogan, MD|
|Principal Investigator:||Eric Grogan, MD||Vanderbilt-Ingram Cancer Center|