Early Detection of Lung Cancer

Study Overview
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Brief Summary
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This research trial studies the long term follow-up for early detection of lung cancer in current or former smokers. Following up on smokers by collecting and analyzing specimens in the laboratory, performing chest computed tomography (CT) scans, as well as reviewing medical records may help doctors detect lung cancer at an earlier stage.

Detailed Description
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PRIMARY OBJECTIVES: I. To provide screening for lung cancer in an underserved and high risk population for lung cancer. II. To collect clinical and demographic information and research bio specimens prospectively on high risk individuals. III. To analyze the association between suspected lung cancer risk factors and outcomes such as pre-malignant lesions and diagnosis of lung cancer. IV. To identify and validate biomarkers that are associated with lung cancer risk factors and premalignant lesions. V. To assess the association between patient characteristics and test results to the genetic and histological characteristics of lung preinvasive lesions and cancers. VI. To describe this high-risk cohort and to identify the patients eligible for future clinical trials (e.g. chemoprevention). OUTLINE: Patients are followed up at 1, 2, 3, 4, and 5 years and undergo collection of sputum, nasal epithelium, buccal epithelium, blood, and urine samples. Patients also undergo pulmonary function tests, chest CT, and review of medical records.

Official Title
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Early Detection of Lung Cancer in the Medically Underserved Population

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Procedure: Biospecimen collection
* Procedure: Biospecimen collection
* Procedure: Biospecimen collection
* Procedure: Biospecimen collection
* Procedure: Pulmonary Function Test
* Procedure: Computed Tomography (CT)
* Other: Laboratory Biomarker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current smoker or former smoker, if former smoker participants must have quit smoking within the past 15 years >= 30 pack year of smoking history Participant is uninsured 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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Screening<br>Patients are followed up at 1, 2, 3, 4, and 5 years and undergo collection of sputum, nasal epithelium, buccal epithelium, blood, and urine samples. Patients also undergo pulmonary function tests, chest CT, and review of medical records | Procedure: Biospecimen Collection<br>* Undergo collection of sputum<br>Procedure: Biospecimen collection<br>* Undergo collection of nasal epithelium<br>Procedure: Biospecimen collection<br>* Undergo collection of buccal epithelium<br>Procedure: Biospecimen collection<br>* Undergo collection of blood<br>Procedure: Biospecimen collection<br>* Undergo collection of urine<br>Procedure: Pulmonary Function Test<br>* Undergo pulmonary function test<br>Procedure: Computed Tomography (CT)<br>* Undergo chest CT<br>* Other names: Undergo chest CT;Other: Laboratory Biomarker<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Candidate biomarkers of risk or of early diagnosis | Will validate the performance of the candidate biomarkers of risk or of early diagnosis. | Up to 5 years. |