Lung Cancer Biomarkers and Screening (NYULCBC)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||NYU Lung Cancer Biomarker Center|
- Lung cancer diagnosis as measured by CT scan findings and pathology findings annually [ Time Frame: 07/01/2015 ] [ Designated as safety issue: No ]
- Precancerous lung nodules as measured by CT scan findings and pathology findings annually [ Time Frame: 07/01/2015 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
blood serum, plasma, urine, sputum, BAL, lung tissue, buccal swab
|Study Start Date:||May 2000|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
lung cancer screening cohort
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
observational only. no intervention. patients with CT findings suspicious for lung cancer who are undergoing bronchoscopy and/or surgery.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301119
|Contact: William N Rom, MD, MPHfirstname.lastname@example.org|
|Contact: Ellen M Eylers, RN, MSN, MPHemail@example.com|
|United States, New York|
|NYU Cancer Institute at New York University Medical Center||Recruiting|
|New York, New York, United States, 10016|
|Contact: William N. Rom, MD, MPH 212-263-6479 firstname.lastname@example.org|
|Principal Investigator:||William N. Rom, MD, MPH||New York University School of Medicine|