Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
480 participants
OBSERVATIONAL
2011-04-30
2026-11-30
Brief Summary
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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
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Screening
These high-risk subjects will undergo screening for lung cancer. All subjects will undergo all listed interventions
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.
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.
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.
Buccal epithelium collection
Collect cells from the inside of the cheek. Samples will be collected at baseline and yearly to year 5.
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.
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.
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.
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.
Urine sample
Urine will be collected for routine urine tests at baseline and yearly to year 5.
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.
Interventions
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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.
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.
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.
Buccal epithelium collection
Collect cells from the inside of the cheek. Samples will be collected at baseline and yearly to year 5.
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.
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.
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.
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.
Urine sample
Urine will be collected for routine urine tests at baseline and yearly to year 5.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.)
55 Years
80 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Eric Grogan
Associate Professor - Thoracic Surgery
Principal Investigators
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Eric Grogan, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
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Veterans Administration
Nashville, Tennessee, United States
Vanderbilt University, Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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References
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Lakhani DA, Chen SC, Antic S, Muterspaugh A, Cook C, Liu N, Shujat H, Jouan S, Winston B, Fields K, Wenstrup J, Block SL, Hinton A, Miller A, Atmajoana S, Helton JT, Patel K, Balar AB, Brewer K, Nag S, Singh R, Disher A, Huerta L, Fremont R, Rickman O, Chen H, Eisenberg R, Sandler KL, Paulson A, Walker RC, Shah C, Smith GT, Landman B, Deppen S, Grogan EL, Aldrich MC, Massion PP. Establishing a Cohort and a Biorepository to Identify Biomarkers for Early Detection of Lung Cancer: The Nashville Lung Cancer Screening Trial Cohort. Ann Am Thorac Soc. 2021 Jul;18(7):1227-1234. doi: 10.1513/AnnalsATS.202004-344OC.
Other Identifiers
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VICC THO 1078
Identifier Type: -
Identifier Source: org_study_id