|No phase specified||Biomarker/Laboratory analysis, Diagnostic, Screening||Active||Over 50||Other||CDR0000456198|
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.
Further Study Information
- 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.
- 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)
- Not pregnant
- No prior malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
- Not specified
Trial Lead Organizations/Sponsors
NYU Cancer Institute at New York University Medical Center
|William N. Rom||Principal Investigator|
|William N Rom, MD, MPH||Ph: 212-263-6479|
|NYU Cancer Institute at New York University Medical Center|
|William N. Rom, MD, MPH||Ph: 212-263-6479|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00301119
ClinicalTrials.gov processed this data on December 10, 2013
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