Lung Cancer Biomarkers and Screening

Study Overview
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Brief Summary
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RATIONALE: Screening tests that use biomarkers may help doctors find tumor cells early and plan effective treatment for lung cancer. PURPOSE: This clinical trial is studying biomarkers in screening participants for lung cancer.

Detailed Description
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OBJECTIVES: Identify and validate biomarkers for the early detection of lung cancer in individuals at low- or high-risk for smoking-related cancers. Identify preneoplastic cellular changes and lesions in these patients. OUTLINE: Participants are stratified according to lung cancer risk status (with or without increased risk). Group 1 (screening cohort): Participants complete a questionnaire and undergo pulmonary function testing, multidetector chest CT scan, sputum induction, and phlebotomy. Group 2 (rule-out lung cancer): Participants complete the same questionnaire and undergo the same tests and scans as in group 1. Some participants may undergo fiberoptic bronchoscopy based upon CT scan results with transbronchial or endobronchial biopsies. Some participants may undergo lung resection. Tissue samples are collected from surgery or biopsy. PROJECTED ACCRUAL: A total of participants will be accrued for this study.

Official Title
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NYU Lung Cancer Biomarker Center

Conditions
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Lung Cancer

Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Screening Cohort At high- or low-risk for lung cancer Smoking history ≥ 20 pack years* With or without workplace exposure to asbestos NOTE: * Participants with < 20 pack years of smoking are eligible if 50 years of age or older Rule-Out Lung cancer group Referred for evaluation of suspicious nodules with 1 of the following diagnoses: Lung cancer Nonmalignant nodules (control group) PATIENT CHARACTERISTICS: Not pregnant No prior malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| lung cancer screening cohort<br>observational only. no intervention. current, former and never smokers over age 50 without history of cancer, except for non melanoma skin cancer, no previous treatment with chemotherapy. | |
| r/o lung cancer<br>observational only. no intervention. patients with CT findings suspicious for lung cancer who are undergoing bronchoscopy and/or surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung cancer diagnosis as measured by CT scan findings and pathology findings annually |  | 07/01/2015 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Precancerous lung nodules as measured by CT scan findings and pathology findings annually |  | 07/01/2015 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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small cell lung cancer, non-small cell lung cancer, smoker lung cancer screening, low dose spiral CT screening