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Lung Cancer Biomarkers and Screening
Conditions
Lung Cancer
Conditions: official terms
Lung Neoplasms
Conditions: Keywords
small cell lung cancer, non-small cell lung cancer, smoker lung cancer screening, low dose spiral CT screening
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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.
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.
- 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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 50 Years
Gender: Both
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
- 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
Location
NYU Cancer Institute at New York University Medical Center
New York, New York, United States
Status: Recruiting
Contact: William N. Rom, MD, MPH - 212-263-6479 - william.rom@med.nyu.edu
Start Date
May 2000
Sponsors
New York University School of Medicine
Source
New York University School of Medicine
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page