Lung Cancer
Conditions
Keywords
small cell lung cancer, non-small cell lung cancer, smoker lung cancer screening, low dose spiral CT screening
Brief summary
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
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.
Interventions
None listed
Sponsors
NYU Langone Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lung cancer diagnosis as measured by CT scan findings and pathology findings annually | 07/01/2015 |
Secondary
| Measure | Time frame |
|---|---|
| Precancerous lung nodules as measured by CT scan findings and pathology findings annually | 07/01/2015 |
Countries
United States
Contacts
CONTACTJames J. Tsay, MD, MSc
CONTACTRosemary M Schluger
PRINCIPAL_INVESTIGATORJames J. Tsay, MD, MSc
NYU Langone Health
Outcome results
None listed